28 Audit Specialist jobs in Malaysia

AUDIT SPECIALIST

Johor, Johor MYFutureJobs

Posted 2 days ago

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Job Description

The Audit Specialist will be responsible for conducting regular audits across apparel manufacturing operations, including process audits, brand protection audits, 6S audits, and MES audits. This role ensures compliance, identifies risks, drives improvement actions, and supports factory alignment with operational standards.

Responsibilities

  • Conduct regular audits across apparel manufacturing operations
  • Perform process audits, brand protection audits, 6S audits, and MES audits
  • Ensure compliance and identify risks
  • Drive improvement actions
  • Support factory alignment with operational standards

Qualifications

  • Minimum 2 years of experience

Required Skills

Seniority level
  • Executive
Employment type
  • Full-time
Job function
  • Accounting/Auditing
Industries
  • Textile Manufacturing

Note: The job posting appears current, with no indication of expiration.

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AUDIT SPECIALIST

Johor Bahru, Johor MYFutureJobs

Posted today

Job Viewed

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Job Description

The Audit Specialist will be responsible for conducting regular audits across apparel manufacturing operations, including process audits, brand protection audits, 6S audits, and MES audits. This role ensures compliance, identifies risks, drives improvement actions, and supports factory alignment with operational standards. Responsibilities Conduct regular audits across apparel manufacturing operations Perform process audits, brand protection audits, 6S audits, and MES audits Ensure compliance and identify risks Drive improvement actions Support factory alignment with operational standards Qualifications Minimum 2 years of experience Required Skills Seniority level

Executive Employment type

Full-time Job function

Accounting/Auditing Industries

Textile Manufacturing Note: The job posting appears current, with no indication of expiration.

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Third Party Risk Assessment Analyst

AutomateBuddy Technologies Private Limited

Posted 12 days ago

Job Viewed

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Job Description

  • The Contractor - Third Party Risk Assessment Analyst will be responsible for evaluating the security and compliance posture of third-party vendors and partners. This role involves identifying potential risks, assessing mitigation measures, and ensuring that third-party relationships align with FWD's security policies and regulatory requirements.
Responsibilities
  • Conduct comprehensive risk assessments of third-party vendors and partners.
  • Evaluate vendors' security policies, procedures, and controls to ensure they meet FWD's standards.
  • Identify potential risks associated with third-party relationships and recommend appropriate mitigation measures.
  • Collaborate with internal stakeholders to gather necessary information and ensure a thorough assessment process.
  • Maintain up-to-date records of third-party risk assessments and findings.
  • Provide detailed reports and risk ratings for third-party vendors.
  • Assist in the development and improvement of third-party risk management policies and procedures.
  • Monitor and track remediation efforts by third parties to address identified risks.
  • Stay current with industry best practices, regulatory requirements, and emerging threats related to third-party risk management.
Required Skills
  • Bachelor’s degree in Information Security, Risk Management, Business Administration, or a related field.
  • 3 or more years of experience in third-party risk assessment, vendor management, or a related area.
  • Strong understanding of information security principles, risk management frameworks, and regulatory requirements (e.g., GDPR, CCPA, PCI-DSS).
  • Experience with risk assessment methodologies and tools.
  • Excellent analytical and problem-solving skills.
  • Strong communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders.
  • Detail-oriented with strong organizational skills.
  • Relevant certifications (e.g., CISA, CISM, CISSP, CRISC) are a plus.
Required Qualification
  • Experience working in the financial industry.
  • Familiarity with third-party risk management software and platforms.
  • Ability to manage multiple assessments simultaneously and meet deadlines.
Apply Now

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Third Party Risk Assessment Analyst

Kelantan, Kelantan AutomateBuddy Technologies Private Limited

Posted today

Job Viewed

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Job Description

The Contractor - Third Party Risk Assessment Analyst will be responsible for evaluating the security and compliance posture of third-party vendors and partners. This role involves identifying potential risks, assessing mitigation measures, and ensuring that third-party relationships align with FWD's security policies and regulatory requirements. Responsibilities

Conduct comprehensive risk assessments of third-party vendors and partners. Evaluate vendors' security policies, procedures, and controls to ensure they meet FWD's standards. Identify potential risks associated with third-party relationships and recommend appropriate mitigation measures. Collaborate with internal stakeholders to gather necessary information and ensure a thorough assessment process. Maintain up-to-date records of third-party risk assessments and findings. Provide detailed reports and risk ratings for third-party vendors. Assist in the development and improvement of third-party risk management policies and procedures. Monitor and track remediation efforts by third parties to address identified risks. Stay current with industry best practices, regulatory requirements, and emerging threats related to third-party risk management. Required Skills

Bachelor’s degree in Information Security, Risk Management, Business Administration, or a related field. 3 or more years of experience in third-party risk assessment, vendor management, or a related area. Strong understanding of information security principles, risk management frameworks, and regulatory requirements (e.g., GDPR, CCPA, PCI-DSS). Experience with risk assessment methodologies and tools. Excellent analytical and problem-solving skills. Strong communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders. Detail-oriented with strong organizational skills. Relevant certifications (e.g., CISA, CISM, CISSP, CRISC) are a plus. Required Qualification

Experience working in the financial industry. Familiarity with third-party risk management software and platforms. Ability to manage multiple assessments simultaneously and meet deadlines. Apply Now

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Associate Director Risk Assessment Monitoring and Insight, Risk

Kuala Lumpur, Kuala Lumpur Standard Chartered

Posted 12 days ago

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Job Description

Associate Director Risk Assessment Monitoring and Insight, Risk

Join to apply for the Associate Director Risk Assessment Monitoring and Insight, Risk role at Standard Chartered

Associate Director Risk Assessment Monitoring and Insight, Risk

2 months ago Be among the first 25 applicants

Join to apply for the Associate Director Risk Assessment Monitoring and Insight, Risk role at Standard Chartered

Job Summary

This role reflects our commitment to more than just profitability—it's about living our values and upholding our brand promise, Here for Good. The Managed Services team, established to support Group Risk and CFCR, centralizes the production and risk management activities in a service hub. This allows teams to make risk-reward decisions based on judgment and expertise, influence business and regulatory outcomes and oversee strategic risk and compliance programs, such as Fit for Growth (FFG) and the Controls Simplification Programme

Job Summary

This role reflects our commitment to more than just profitability—it's about living our values and upholding our brand promise, Here for Good. The Managed Services team, established to support Group Risk and CFCR, centralizes the production and risk management activities in a service hub. This allows teams to make risk-reward decisions based on judgment and expertise, influence business and regulatory outcomes and oversee strategic risk and compliance programs, such as Fit for Growth (FFG) and the Controls Simplification Programme

This is a global support role, covering SCB's presence across Asia, Africa, the Middle East, Europe, and the Americas, and spans multiple business lines such as Retail Banking, Private Banking, Wealth Management, Transaction Banking, and Financial Markets.

Key Responsibilities

  • Risk Assessment: support the performance of both inherent and residual risk assessments (regular, dynamic and targeted).
  • Control Monitoring: Support the control design effectiveness assessment, and dynamically monitor risk and controls.
  • Change Risk: Assess and manage risks associated with change initiatives.
  • Issue & Event Management: Support in the management of issues and events, escalate as needed, and ensure timely reporting.
  • Risk Insights: Provide actionable risk insights to business stakeholders.
  • Data Quality: Identify and remediate data quality issues, including administration, reporting and ownership of resolution. Ensure data models are up to date and accurate.
  • Horizon Scanning: support horizon scanning product and related Knowledge Management System
  • FFG Programme: support the overall embedding and transitioning of new technology solutions (e.g. AI capabilities) into various risk processes.
  • Governance: document processes and procedures to ensure transition of services to the Managed Service team are accurate, up to date and centrally stored and available.
  • Help build world-class risk and compliance capabilities, fostering a risk-aware and client-focused environment for the bank’s next phase of growth.
  • Deliver simplified, standardized, and digitized solutions that meet compliance obligations while providing insights to the 1st Line of Defence (1LoD) for better decision-making.
  • Execution of risk assessment, monitoring and insight processes.
  • Enhance and simplify controls related to OTCR (Operational, Technology, and Cyber Risk), where appropriate.
  • Capture lessons learnt and refine tooling and processes improvements.
  • Identify insights, analyse, and assess OTCR risks and implementing control frameworks to manage these risks.
  • Development of basic MI to support Coverage and SME actions (i.e., trends).
  • Conduct deep dives into material, emerging, or unknown risks to enable appropriate risk mitigation.
  • Manage issues as they arise, performing root cause analysis, lessons learned, and remediation efforts.
  • Address data quality issues and ensure data models are up to date and accurate, notably those that are related to implemented AI use cases and capabilities.
  • Maintain Knowledge Management Systems that enable and support risk products and microservices.
  • Implement a risk-based compliance framework for managing OTCR risks.
  • Recommend risk assessment standards across OTCR risk types, ensuring compliance with all relevant regulations.
  • Escalate potential OTCR risks to management.
  • Support the end-to-end lifecycle of audit, assurance, and regulatory reviews related to Professional Services, including tracking and remediation.

Skills And Experience

Overall Working Experience:

  • Overall experience in Banking or Financial Institution or Regulator or Fintech or equivalent industry

Business & Contextual Experience in at least one of the below:

  • Retail Banking
  • Wealth Management
  • Private Banking
  • Transaction Banking – Trade
  • Transaction Banking – Cash Management
  • Markets (e.g., Sales & Trading, Global Credit Markets, Private Side)

Domain And Functional Experience In One Of The Below

  • OTCR – Operational, Technology and Cyber Risk
  • Conduct & Compliance Risks
  • Data Risk
  • Conflict of Interest
  • Non-Financial Regulatory Reporting
  • Regulatory Conduct
  • Market Conduct
  • Client Conduct
  • Financial Crime Risks
  • Anti-Money Laundering
  • Anti-Bribery & Corruption
  • Sanctions
  • Fraud (Internal and External)
  • Experience in Business or Product or Operations Risk Management with exposure to Conduct or Compliance or Financial Crime or Control Oversight in a front or first-line role, and/or

Other Experience

  • Well versed with tools and techniques of analysing potential risk exposures
  • Understanding of effective communication skills.
  • Understanding of best practice risk assessment techniques and risk management frameworks.
  • Understanding of the key features of relevant laws and regulations relevant to the Group
  • Sound judgement on business practices, regulatory relationship management and reputational risk,
  • Ability to balance both detail oriented and big picture perspectives.
  • Ability to collaborate and work dynamically across functions.

Key stakeholders*

  • Global Compliance Officers covering Business or Products or Client Segments or Clusters, and their respective team.
  • Chief Country Compliance Officers covering Countries, and their respective team.
  • Global Product Owners covering respective CFCC & Risk products.
  • Global and Country Business Heads
  • Global and Country Business Risk Management
  • Global and Country Process Leads
  • Chief Data Officer and teams involved in developing Data analytical products.
  • Global Head Technology involved in developing technology solutions and regulatory technology products.
  • Audit & Assurance teams

Qualifications

  • We value your practical and hands-on experience in the above domains .
  • Any industry certifications in the Risk & CFCR domains are most welcome (e.g., IRM, CISSP, ACAMS, ICA).
  • Any industry certifications in the Business or Product domain are most welcome

About Standard Chartered

We're an international bank, nimble enough to act, big enough for impact. For more than 170 years, we've worked to make a positive difference for our clients, communities, and each other. We question the status quo, love a challenge and enjoy finding new opportunities to grow and do better than before. If you're looking for a career with purpose and you want to work for a bank making a difference, we want to hear from you. You can count on us to celebrate your unique talents and we can't wait to see the talents you can bring us.

Our purpose, to drive commerce and prosperity through our unique diversity, together with our brand promise, to be here for good are achieved by how we each live our valued behaviours. When you work with us, you'll see how we value difference and advocate inclusion.

Together We

  • Do the right thing and are assertive, challenge one another, and live with integrity, while putting the client at the heart of what we do
  • Never settle, continuously striving to improve and innovate, keeping things simple and learning from doing well, and not so well
  • Are better together, we can be ourselves, be inclusive, see more good in others, and work collectively to build for the long term

What We Offer

In line with our Fair Pay Charter, we offer a competitive salary and benefits to support your mental, physical, financial and social wellbeing.

  • Core bank funding for retirement savings, medical and life insurance, with flexible and voluntary benefits available in some locations.
  • Time-off including annual leave, parental/maternity (20 weeks), sabbatical (12 months maximum) and volunteering leave (3 days), along with minimum global standards for annual and public holiday, which is combined to 30 days minimum.
  • Flexible working options based around home and office locations, with flexible working patterns.
  • Proactive wellbeing support through Unmind, a market-leading digital wellbeing platform, development courses for resilience and other human skills, global Employee Assistance Programme, sick leave, mental health first-aiders and all sorts of self-help toolkits
  • A continuous learning culture to support your growth, with opportunities to reskill and upskill and access to physical, virtual and digital learning.
  • Being part of an inclusive and values driven organisation, one that embraces and celebrates our unique diversity, across our teams, business functions and geographies - everyone feels respected and can realise their full potential.

Seniority level
  • Seniority level Mid-Senior level
Employment type
  • Employment type Full-time
Job function
  • Job function Finance and Sales
  • Industries Banking

Referrals increase your chances of interviewing at Standard Chartered by 2x

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Audit Specialist (6 months contract – Hybrid) | US MNC

Kuala Lumpur, Kuala Lumpur Career Horizons

Posted 18 days ago

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Job Description

Job Description

• Take the lead during the statutory audit and tax return process.

• Follow up closely with respective stakeholders.

• Prepare/update the outstanding list on a weekly basis.

The audit and tax return job scope includes:

  1. Accounts Receivable (AR)
  2. Accounts Payable (AP)
  3. Intercompany
  4. Fixed Assets
  5. Cash and Bank Balances
  6. Property, Plant and Equipment
  7. Inventory
  8. Prepayment
  9. Accrual provision and other liabilities
  10. Current and deferred income tax
  11. Income Statement related (Revenue, Cost of Goods Sold, Operating expenses)
  12. Inputting information for draft audit report
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Audit Specialist (6 months contract – Hybrid) | US MNC

Kuala Lumpur, Kuala Lumpur Career Horizons

Posted today

Job Viewed

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Job Description

Job Description

• Take the lead during the statutory audit and tax return process.

• Follow up closely with respective stakeholders.

• Prepare/update the outstanding list on a weekly basis.

The audit and tax return job scope includes:

Accounts Receivable (AR)

Accounts Payable (AP)

Intercompany

Fixed Assets

Cash and Bank Balances

Property, Plant and Equipment

Inventory

Prepayment

Accrual provision and other liabilities

Current and deferred income tax

Income Statement related (Revenue, Cost of Goods Sold, Operating expenses)

Inputting information for draft audit report

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IT Resilience, Audit and Risk Specialist

Petaling Jaya, Selangor Roche

Posted 12 days ago

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Job Description

IT Resilience, Audit and Risk Specialist

Join to apply for the IT Resilience, Audit and Risk Specialist role at Roche

IT Resilience, Audit and Risk Specialist

2 days ago Be among the first 25 applicants

Join to apply for the IT Resilience, Audit and Risk Specialist role at Roche

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

The Position:

Are you a compliance expert with a solid background in IT security, data privacy, quality compliance and regulatory requirements—particularly within agency-governed environments? Are you looking for a challenging, innovative, fun and collaborative workspace where you can grow your expertise while making an impact? If so, the Security, Quality, and Compliance Chapter wants to hear from you!

As a Specialist in IT Risk, Audit and Compliance, you will be an integral part of our diverse Informatics community of smart, fun, wholehearted, and engaged professionals spanning diverse functional areas. You will share our community values of passion, courage, integrity, and gratitude -- all in service of our mission, “doing now what patients need next.”

Your primary accountability is to provide expert guidance in ensuring that our IT systems and processes are compliant and aligned with applicable regulations, GxP validation methodology, SDLC, up-to-date process controls, and that risks are being managed prudently. By being deeply engaged with our stakeholders ranging from, but are not limited to, business partners, quality, procurement, and security professionals, you will demonstrate an expert understanding of GxP-related safety, clinical and medical data and build a strong framework to assess the quality and security of our systems. Professionally you demonstrate exceptional competency in supporting internal audit and external inspections.

Your success requires a blend of specialized knowledge, practical experience, and strong organizational skills. You are self-motivated and have the ability to motivate your teammates to bring impact to business value streams. As a Specialist in IT Risk, Audit and Compliance, you foster a positive team culture and collaboration with peers, establish strong relationships and manage stakeholders across the globe. You are someone who can negotiate and influence at all levels.

Responsibilities:

  • Conduct internal review of IT systems and processes, ensure compliance with validation methodology, SDLC, security / privacy policies, and applicable regulatory requirements
  • Communicate the results of internal review to stakeholders (written reports / oral presentations). Establish and build working relationships with SME and stakeholders
  • Exhibits intellectual curiosity and sound judgment to influence and challenge SME
  • Fostering innovation and simplification, seeking solutions to improve and simplify existing processes, and creating a culture that encourages creativity and continuous improvement
  • Conduct risk assessments to identify potential threats and vulnerabilities within the IT Systems and platforms
  • Audit and inspection Support: Provide support during internal audit or external inspections. Where applicable, collaborate and partner with applicable audit and inspection teams to resolve issues and facilitate efficient processes. Ensure comprehensive preparation, documentation readiness, and seamless execution of audit activities while maintaining compliance with GxP regulations
  • Support post-Inspection Activities. Compile audit/inspection findings and coordinate response development. Support CAPA (corrective and preventive action) planning, implementation and tracking
  • Stakeholder management for business partners and subject matter / functional experts
  • Participate in ongoing enhancement initiatives and continuous improvement assignments

The Ideal Candidate:

Has a diverse background, adept at managing change during challenging periods, and excels at resolving issues and finding solutions. Wants to tackle the biggest healthcare challenges that face us globally in the 21st century. Excel at relationship building and networking. Has demonstrated the ability to navigate complexity, is pragmatic, sees the big picture, and can give examples of impact in a large global organization.

Qualifications:

  • Bachelor’s degree in Life Science, Informatics, Quality, or related field. Master’s degree or post-graduate coursework are desirable.
  • 5+ years of related experience, domain knowledge of the pharmaceutical industry in Internal and External audit management / regulatory inspection
  • Knowledge of GxP regulations. Familiarity with industry regulations and governance such as: IT Computer Systems: FDA 21 CFR Part 11, HIPAA (Health Insurance Portability and Accountability Act), GDPR (General Data Protection Regulation), ISO/IEC 27001, NIST (National Institute of Standards and Technology), PCI DSS (Payment Card Industry Data Security Standard). Validation Methodology/SDLC: IEEE Standards, ISO/IEC 12207, GxP Guidelines, GAMP, EU Annex 11, ICH Guidelines, PIC/S
  • Solid understanding of computerized validation processes and requirements for 3rd party software and service providers in the pharmaceutical industry
  • Experience leading cross-functional collaborative team environments, provide innovative solutions to complex business problems and make decisions with cross-functional impact
  • Effective influence skills to communicate internal review findings, both verbally and in writing
  • Strong communication skills - ability to communicate efficiently complex information, issues, and potential solutions
  • Demonstrated ability to quickly learn business priorities in unfamiliar or ambiguous areas
  • Strong organizational and project management skills
  • Proven skills in relationship building, customer-focus, decision-making, and problem solving
  • Proven track record in adoption and use of innovative techniques
  • Ability to juggle multiple work efforts and to quickly change direction
  • Experience or understanding of Internal Control over Financial Reporting (ICFR) is a plus

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.

Seniority level
  • Seniority level Associate
Employment type
  • Employment type Full-time
Job function
  • Job function Information Technology
  • Industries Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing

Referrals increase your chances of interviewing at Roche by 2x

Sign in to set job alerts for “Audit” roles.

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IT Resilience, Audit and Risk Specialist

Petaling Jaya, Selangor F. Hoffmann-La Roche Gruppe

Posted 17 days ago

Job Viewed

Tap Again To Close

Job Description

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

The Position:

Are you a compliance expert with a solid background in IT security, data privacy, quality compliance and regulatory requirements—particularly within agency-governed environments? Are you looking for a challenging, innovative, fun and collaborative workspace where you can grow your expertise while making an impact? If so, the Security, Quality, and Compliance Chapter wants to hear from you!

As a Specialist inIT Risk, Audit and Compliance, you will be an integral part of our diverse Informatics community of smart, fun, wholehearted, and engaged professionals spanning diverse functional areas. You will share our community values of passion, courage, integrity, and gratitude -- all in service of our mission, “doing now what patients need next.”

Your primary accountability is to provide expert guidance in ensuring that our IT systems and processes are compliant and aligned with applicable regulations, GxP validation methodology, SDLC, up-to-date process controls, and that risks are being managed prudently. By being deeply engaged with our stakeholders ranging from, but are not limited to, business partners, quality, procurement, and security professionals, you will demonstrate an expert understanding of GxP-related safety, clinical and medical data and build a strong framework to assess the quality and security of our systems. Professionally you demonstrate exceptional competency in supporting internal audit and external inspections.

Your success requires a blend of specialized knowledge, practical experience, and strong organizational skills. You are self-motivated and have the ability to motivate your teammates to bring impact to business value streams. As a Specialist in IT Risk, Audit and Compliance, you foster a positive team culture and collaboration with peers, establish strong relationships and manage stakeholders across the globe. You are someone who can negotiate and influence at all levels.

Responsibilities:

  • Conduct internal review of IT systems and processes, ensure compliance with validation methodology, SDLC, security / privacy policies, and applicable regulatory requirements

  • Communicate the results of internal review to stakeholders (written reports / oral presentations). Establish and build working relationships with SME and stakeholders

  • Exhibits intellectual curiosity and sound judgment to influence and challenge SME

  • Fostering innovation and simplification, seeking solutions to improve and simplify existing processes, and creating a culture that encourages creativity and continuous improvement

  • Conduct risk assessments to identify potential threats and vulnerabilities within the IT Systems and platforms

  • Audit and inspection Support: Provide support during internal audit or external inspections. Where applicable, collaborate and partner with applicable audit and inspection teams to resolve issues and facilitate efficient processes. Ensure comprehensive preparation, documentation readiness, and seamless execution of audit activities while maintaining compliance with GxP regulations

  • Support post-Inspection Activities. Compile audit/inspection findings and coordinate response development. Support CAPA (corrective and preventive action) planning, implementation and tracking.

  • Stakeholder management for business partners and subject matter / functional experts.

  • Participate in ongoing enhancement initiatives and continuous improvement assignments

The Ideal Candidate:

Has a diverse background, adept at managing change during challenging periods, and excels at resolving issues and finding solutions. Wants to tackle the biggest healthcare challenges that face us globally in the 21st century. Excel at relationship building and networking. Has demonstrated the ability to navigate complexity, is pragmatic, sees the big picture, and can give examples of impact in a large global organization.

Qualifications:

  • Bachelor’s degree in Life Science, Informatics, Quality, or related field. Master’s degree or post-graduate coursework are desirable.

  • 5+ years of related experience, domain knowledge of the pharmaceutical industry in Internal and External audit management / regulatory inspection

  • Knowledge of GxP regulations. Familiarity with industry regulations and governance such as: IT Computer Systems: FDA 21 CFR Part 11, HIPAA (Health Insurance Portability and Accountability Act), GDPR (General Data Protection Regulation), ISO/IEC 27001, NIST (National Institute of Standards and Technology), PCI DSS (Payment Card Industry Data Security Standard). Validation Methodology/SDLC: IEEE Standards, ISO/IEC 12207, GxP Guidelines, GAMP, EU Annex 11, ICH Guidelines, PIC/S.

  • Solid understanding of computerized validation processes and requirements for 3rd party software and service providers in the pharmaceutical industry

  • Experience leading cross-functional collaborative team environments, provide innovative solutions to complex business problems and make decisions with cross-functional impact

  • Effective influence skills to communicate internal review findings, both verbally and in writing

  • Strong communication skills - ability to communicate efficiently complex information, issues, and potential solutions.

  • Demonstrated ability to quickly learn business priorities in unfamiliar or ambiguous areas

  • Strong organizational and project management skills

  • Proven skills in relationship building, customer-focus, decision-making, and problem solving

  • Proven track record in adoption and use of innovative techniques

  • Ability to juggle multiple work efforts and to quickly change direction

  • Experience or understanding of Internal Control over Financial Reporting (ICFR) is a plus

Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.


Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.

#J-18808-Ljbffr
This advertiser has chosen not to accept applicants from your region.

IT Resilience, Audit and Risk Specialist

Petaling Jaya, Selangor Roche

Posted today

Job Viewed

Tap Again To Close

Job Description

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position

The Position: Are you a compliance expert with a solid background in IT security, data privacy, quality compliance and regulatory requirements—particularly within agency-governed environments? Are you looking for a challenging, innovative, fun and collaborative workspace where you can grow your expertise while making an impact? If so, the Security, Quality, and Compliance Chapter wants to hear from you! As a Specialist in IT Risk, Audit and Compliance, you will be an integral part of our diverse Informatics community of smart, fun, wholehearted, and engaged professionals spanning diverse functional areas. You will share our community values of passion, courage, integrity, and gratitude -- all in service of our mission, “doing now what patients need next.” Your primary accountability is to provide expert guidance in ensuring that our IT systems and processes are compliant and aligned with applicable regulations, GxP validation methodology, SDLC, up-to-date process controls, and that risks are being managed prudently. By being deeply engaged with our stakeholders ranging from, but are not limited to, business partners, quality, procurement, and security professionals, you will demonstrate an expert understanding of GxP-related safety, clinical and medical data and build a strong framework to assess the quality and security of our systems. Professionally you demonstrate exceptional competency in supporting internal audit and external inspections. Your success requires a blend of specialized knowledge, practical experience, and strong organizational skills. You are self-motivated and have the ability to motivate your teammates to bring impact to business value streams. As a Specialist in IT Risk, Audit and Compliance, you foster a positive team culture and collaboration with peers, establish strong relationships and manage stakeholders across the globe. You are someone who can negotiate and influence at all levels. Responsibilities: Conduct internal review of IT systems and processes, ensure compliance with validation methodology, SDLC, security / privacy policies, and applicable regulatory requirements

Communicate the results of internal review to stakeholders (written reports / oral presentations). Establish and build working relationships with SME and stakeholders

Exhibits intellectual curiosity and sound judgment to influence and challenge SME

Fostering innovation and simplification, seeking solutions to improve and simplify existing processes, and creating a culture that encourages creativity and continuous improvement

Conduct risk assessments to identify potential threats and vulnerabilities within the IT Systems and platforms

Audit and inspection Support: Provide support during internal audit or external inspections. Where applicable, collaborate and partner with applicable audit and inspection teams to resolve issues and facilitate efficient processes. Ensure comprehensive preparation, documentation readiness, and seamless execution of audit activities while maintaining compliance with GxP regulations

Support post-Inspection Activities. Compile audit/inspection findings and coordinate response development. Support CAPA (corrective and preventive action) planning, implementation and tracking.

Stakeholder management for business partners and subject matter / functional experts.

Participate in ongoing enhancement initiatives and continuous improvement assignments

The Ideal Candidate: Has a diverse background, adept at managing change during challenging periods, and excels at resolving issues and finding solutions. Wants to tackle the biggest healthcare challenges that face us globally in the 21st century. Excel at relationship building and networking. Has demonstrated the ability to navigate complexity, is pragmatic, sees the big picture, and can give examples of impact in a large global organization. Qualifications: Bachelor’s degree in Life Science, Informatics, Quality, or related field. Master’s degree or post-graduate coursework are desirable.

5+ years of related experience, domain knowledge of the pharmaceutical industry in Internal and External audit management / regulatory inspection

Knowledge of GxP regulations. Familiarity with industry regulations and governance such as: IT Computer Systems: FDA 21 CFR Part 11, HIPAA (Health Insurance Portability and Accountability Act), GDPR (General Data Protection Regulation), ISO/IEC 27001, NIST (National Institute of Standards and Technology), PCI DSS (Payment Card Industry Data Security Standard).

Validation Methodology/SDLC: IEEE Standards, ISO/IEC 12207, GxP Guidelines, GAMP, EU Annex 11, ICH Guidelines, PIC/S.

Solid understanding of computerized validation processes and requirements for 3rd party software and service providers in the pharmaceutical industry

Experience leading cross-functional collaborative team environments, provide innovative solutions to complex business problems and make decisions with cross-functional impact

Effective influence skills to communicate internal review findings, both verbally and in writing

Strong communication skills - ability to communicate efficiently complex information, issues, and potential solutions.

Demonstrated ability to quickly learn business priorities in unfamiliar or ambiguous areas

Strong organizational and project management skills

Proven skills in relationship building, customer-focus, decision-making, and problem solving

Proven track record in adoption and use of innovative techniques

Ability to juggle multiple work efforts and to quickly change direction

Experience or understanding of Internal Control over Financial Reporting (ICFR) is a plus

Who we are A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together. Roche is an Equal Opportunity Employer.

#J-18808-Ljbffr
This advertiser has chosen not to accept applicants from your region.
 

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