204 Pharmaceutical Quality jobs in Malaysia

Quality & Compliance Specialist (CSV, GMP, GCP) page is loadedQuality & Compliance Specialist (CSV, GMP, GCP) Candidatar-se locations Petaling Jaya Warsaw time type Tempo integral posted on Publicado há 2 dias job requisition id 202506-115071

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.

As part of the Quality Assurance team, you will be a trusted partner for customers to ensure and improve the overall quality of IT systems throughout their lifecycle. You are a customer-focused, highly collaborative individual who will work with delivery units across both Business and Informatics to advance existing and emerging business critical technology according to Roche’s needs

WHAT YOU’LL BE WORKING ON

You will assure that Roche’s regulated/critical systems and services adhere to regulatory standards (e.g. CSV, GMP, GCP) and regulatory risks are managed adequately to protect Roche business. By providing automated control insights and streamlined monitoring capabilities, an effective and consistent tracking of Information on Quality Oversight is enabled. Governance and processes are provided to comply with GxP, Data privacy laws and regulations when processing and hosting Roche data.

• Participate in the development of new standards and revision of existing standards related to Computer Systems Validation (CSV). Assemble global feedback on proposed or existing standards and tools and provide recommendations for new guidance/standards or revisions to existing guidance/standards. Provide consultation and guidance to delivery and operational units across Informatics on accurate interpretation of Roche CSV approach and requirements

• Provide independent Quality Assurance oversight/support for IT4IT systems (and some business domains) with regard to Computer Systems Validation and other regulatory systems. Escalate non-compliance against quality standards to appropriate governance bodies and Risk Management functions for resolution

• Facilitate and leverage quality practitioners within the delivery units to identify best practices, and lead improvement initiatives across functional areas

STAKEHOLDER MANAGEMENT AND PARTNERING:

• Connect and understand the regulatory and compliance needs in the context of the stakeholders and closely partner with them to develop the strategic direction of the product. Shape the Digitalized Compliance roadmap and portfolio to deliver high value outcomes for the customers of the product. Define and deliver the product roadmap and manage the end-to-end product lifecycle (including continuously facilitating product discovery), ensuring it delivers tangible and meaningful value aligned with customer needs and expected business outcomes

• Collaborate to create the future IT Governance Framework with IT processes and standards to keep these updated with the newest developments of external standards and best practices

• Coordinate, connect and collaborate across informatics to foster a spirit of "One Roche"

IMPACT AND COMPLEXITY

• Define and manage product service levels, governance and operational support model aligned with stakeholder needs . Lead or coordinate quality and compliance discussions. Ensure stability, quality and transparency in all aspects of the product governance and partner with senior/global leaders to ensure compliance with existing and changing regulations

• Demonstrate a working knowledge and implications of general and Roche-specific information security, privacy and regulatory principles and requirements . Ensure that services are designed, delivered and maintained in accordance with applicable information security, privacy and regulatory requirements.Ensure information risk assessment process and implementation guidelines are followed

What you’ll need to be successful

• Exhibits servant and creative leadership (VACC) behavior. Exhibits a Lean-Agile Mindset and excels at Product Management practices. Takes 'progressive risk'--not thrill-seeking, but risk that leads to opportunity

• Has a keen Quality & Regulatory focus: You are passionate about major trends . Demonstrates an executive presence, strong business acumen, ability to navigate ambiguity, and manages complexity

• Has an enterprise mindset that can break down silos. Focus on continuous delivery through collaboration, and bringing people together to work towards the same purpose across organizational boundaries.

• Exhibits ability to empower teams and individuals to act autonomously and hold them accountable . Exhibits intellectual curiosity and integrity and has a strong passion for innovation

• Understanding of health regulatory frameworks (FDA, GxP); Understanding of risk and control frameworks and quality standards including government guidelines and laws (HIPAA, GDPR, experience with control automation

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.

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.

As part of the Quality Assurance team, you will be a trusted partner for customers to ensure and improve the overall quality of IT systems throughout their lifecycle. You are a customer-focused, highly collaborative individual who will work with delivery units across both Business and Informatics to advance existing and emerging business critical technology according to Roche’s needs

WHAT YOU’LL BE WORKING ON

You will assure that Roche’s regulated/critical systems and services adhere to regulatory standards (e.g. CSV, GMP, GCP) and regulatory risks are managed adequately to protect Roche business. By providing automated control insights and streamlined monitoring capabilities, an effective and consistent tracking of Information on Quality Oversight is enabled. Governance and processes are provided to comply with GxP, Data privacy laws and regulations when processing and hosting Roche data.

• Participate in the development of new standards and revision of existing standards related to Computer Systems Validation (CSV).Assemble global feedback on proposed or existing standards and tools and provide recommendations for new guidance/standards or revisions to existing guidance/standards.Provide consultation and guidance to delivery and operational units across Informatics on accurate interpretation of Roche CSV approach and requirements

• Provide independent Quality Assurance oversight/support for IT4IT systems (and some business domains) with regard to Computer Systems Validation and other regulatory systems. Escalate non-compliance against quality standards to appropriate governance bodies and Risk Management functions for resolution

• Facilitate and leverage quality practitioners within the delivery units to identify best practices, and lead improvement initiatives across functional areas

STAKEHOLDER MANAGEMENT AND PARTNERING:

• Connect and understand the regulatory and compliance needs in the context of the stakeholders and closely partner with them to develop the strategic direction of the product. Shape the Digitalized Compliance roadmap and portfolio to deliver high value outcomes for the customers of the product.Define and deliver the product roadmap and manage the end-to-end product lifecycle (including continuously facilitating product discovery), ensuring it delivers tangible and meaningful value aligned with customer needs and expected business outcomes

• Collaborate to create the future IT Governance Framework with IT processes and standards to keep these updated with the newest developments of external standards and best practices

• Coordinate, connect and collaborate across informatics to foster a spirit of "One Roche"

IMPACT AND COMPLEXITY

• Define and manage product service levels, governance and operational support model aligned with stakeholder needs. Lead or coordinate quality and compliance discussions. Ensure stability, quality and transparency in all aspects of the product governance and partner with senior/global leaders to ensure compliance with existing and changing regulations

• Demonstrate a working knowledge and implications of general and Roche-specific information security, privacy and regulatory principles and requirements. Ensure that services are designed, delivered and maintained in accordance with applicable information security, privacy and regulatory requirements.Ensure information risk assessment process and implementation guidelines are followed

What you’ll need to be successful

• Exhibits servant and creative leadership (VACC) behavior. Exhibits a Lean-Agile Mindset and excels at Product Management practices. Takes 'progressive risk'--not thrill-seeking, but risk that leads to opportunity

• Has a keen Quality & Regulatory focus: You are passionate about major trends. Demonstrates an executive presence, strong business acumen, ability to navigate ambiguity, and manages complexity

• Has an enterprise mindset that can break down silos. Focus on continuous delivery through collaboration, and bringing people together to work towards the same purpose across organizational boundaries.

• Exhibits ability to empower teams and individuals to act autonomously and hold them accountable. Exhibits intellectual curiosity and integrity and has a strong passion for innovation

• Understanding of health regulatory frameworks (FDA, GxP); Understanding of risk and control frameworks and quality standards including government guidelines and laws (HIPAA, GDPR, experience with control automation

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.

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.

As part of the Quality Assurance team, you will be a trusted partner for customers to ensure and improve the overall quality of IT systems throughout their lifecycle. You are a customer-focused, highly collaborative individual who will work with delivery units across both Business and Informatics to advance existing and emerging business critical technology according to Roche’s needs

WHAT YOU’LL BE WORKING ON

You will assure that Roche’s regulated/critical systems and services adhere to regulatory standards (e.g. CSV, GMP, GCP) and regulatory risks are managed adequately to protect Roche business. By providing automated control insights and streamlined monitoring capabilities, an effective and consistent tracking of Information on Quality Oversight is enabled. Governance and processes are provided to comply with GxP, Data privacy laws and regulations when processing and hosting Roche data.

• Participate in the development of new standards and revision of existing standards related to Computer Systems Validation (CSV).Assemble global feedback on proposed or existing standards and tools and provide recommendations for new guidance/standards or revisions to existing guidance/standards. Provide consultation and guidance to delivery and operational units across Informatics on accurate interpretation of Roche CSV approach and requirements

• Provide independent Quality Assurance oversight/support for IT4IT systems (and some business domains) with regard to Computer Systems Validation and other regulatory systems. Escalate non-compliance against quality standards to appropriate governance bodies and Risk Management functions for resolution

• Facilitate and leverage quality practitioners within the delivery units to identify best practices, and lead improvement initiatives across functional areas

STAKEHOLDER MANAGEMENT AND PARTNERING:

• Connect and understand the regulatory and compliance needs in the context of the stakeholders and closely partner with them to develop the strategic direction of the product. Shape the Digitalized Compliance roadmap and portfolio to deliver high value outcomes for the customers of the product. Define and deliver the product roadmap and manage the end-to-end product lifecycle (including continuously facilitating product discovery), ensuring it delivers tangible and meaningful value aligned with customer needs and expected business outcomes

• Collaborate to create the future IT Governance Framework with IT processes and standards to keep these updated with the newest developments of external standards and best practices

• Coordinate, connect and collaborate across informatics to foster a spirit of "One Roche"

IMPACT AND COMPLEXITY

• Define and manage product service levels, governance and operational support model aligned with stakeholder needs . Lead or coordinate quality and compliance discussions. Ensure stability, quality and transparency in all aspects of the product governance and partner with senior/global leaders to ensure compliance with existing and changing regulations

• Demonstrate a working knowledge and implications of general and Roche-specific information security, privacy and regulatory principles and requirements . Ensure that services are designed, delivered and maintained in accordance with applicable information security, privacy and regulatory requirements.Ensure information risk assessment process and implementation guidelines are followed

What you’ll need to be successful

• Exhibits servant and creative leadership (VACC) behavior. Exhibits a Lean-Agile Mindset and excels at Product Management practices. Takes 'progressive risk'--not thrill-seeking, but risk that leads to opportunity

• Has a keen Quality & Regulatory focus: You are passionate about major trends . Demonstrates an executive presence, strong business acumen, ability to navigate ambiguity, and manages complexity

• Has an enterprise mindset that can break down silos. Focus on continuous delivery through collaboration, and bringing people together to work towards the same purpose across organizational boundaries.

• Exhibits ability to empower teams and individuals to act autonomously and hold them accountable . Exhibits intellectual curiosity and integrity and has a strong passion for innovation

• Understanding of health regulatory frameworks (FDA, GxP); Understanding of risk and control frameworks and quality standards including government guidelines and laws (HIPAA, GDPR, experience with control automation

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.

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OVERALL PURPOSE OF THE JOB

Responsible for developing, implementing, and maintaining the project’s Quality Management System (QMS). This includes preparing the Project Quality Plan (PQP), Inspection and Test Plans (ITPs), field inspection and testing procedures, internal and external audit plans, and overseeing document control processes to ensure full compliance with contractual and regulatory quality requirements.

PRINCIPLE DUTIES

• Develop and implement the Quality Management System (QMS), Project Quality Plan (PQP), and Inspection & Test Plans (ITPs).
• Conduct inspections and testing for materials, fabrication, welding, coating, and installation activities.
• Identify and manage non-conformances (NCRs), including root cause analysis and corrective actions.
• Plan and perform quality audits on internal teams, vendors, and subcontractors.
• Maintain proper documentation, traceability, and quality records in line with project and client requirements.
• Liaise with client representatives, third-party inspectors, and project team on all quality matters.
• Ensure QAQC compliance with HSE standards and contribute to continuous improvement initiatives.

KNOWLEDGE / EXPERIENCE REQUIRED FOR THE JOB

• Minimum 6 years of experience in the oil and gas industry, with at least 3 years as a QAQC Engineer,
• Experienced in quality audit of oil and gas project execution during procurement, and construction.
• Familiar with international materials standards, pressure/process piping and vessels codes, structural and electrical codes, welding, and NDT codes such as ASME, AWS, ANSI and API, etc.

ACADEMIC / PROFESSIONAL QUALIFICATION

• Diploma in Engineering or equivalent.
• CSWIP 3.1/ PCN level I or equivalent is preferred.
• Attended International Register of Certified Auditors (IRCA) certified ISO 9001 Lead Auditor Cour

• Seniority level Executive

• Employment type Contract

• Job function Quality Assurance
• Industries Oil and Gas

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The Quality and Assurance Engineer provides quality & completions assurance support to Australian projects within ACC from the Kuala Lumpur Gamuda Hub.

1) DTI Values

-Work in accordance with DTI’s values and demonstrate commitment, active involvement and leadership regarding zero harm, client, people, and financial accountabilities.

2)Project Systems Support

-Assist the Project Quality & Completions Manager/s to:

-Develop the register of Project contract completions & handover requirements and track progress against deliverable development.

-Assist project set-up in ACC and Gdos, including uploading the Work Breakdown Structure into -ACC/Gdos and developing the project folder structure as required.

3)Project Quality Assurance

-Conduct daily audits within ACC to ensure folders contain the required list of deliverables by the due dates.

-Provide feedback and advice to the Project quality Team about the completeness of records within the ACC and DGos system.

-Assist with the upload of records to the Gdos and ACC system.

4)Coaching and Training

-Assist project team members to understand the functionality of ACC and Gdos.

-Remain abreast of new features within ACC and Gdos and provide coaching to team members to ensure all are across relevant updates.

-Provide coaching engineering teams to interpret reports to set quality and completions activity priorities on a weekly basis.

5)Reporting

-Reporting and Communication:

-Provide project reporting to assist the team to have visibility of the status of quality and completions records.

-Provide input to project monthly reporting as required.

• Minimum: 5 years’ experience working as a professional engineer within the construction industry (preferably civil or structures).
• Minimum: Experience in using digital systems for the capture of construction quality documentation (as required by the ITP) in support of completions and handover.
• Minimum: Experience in the use of Power BI (or similar tool) to report against construction quality progress.

Preferred / Optional: Experience in checking the completeness of digital quality records in preparation for handover.

Experience:

• Ability to speak, write and understand the English language in relation to construction terminology.
• Ability to work independently and collaboratively in a dynamic environment.
• Ability to review and recommend opportunities for improvement, including gaps or new processes or to streamline transactional activities.

Ability to administer multiple and competing tasks concurrently.

Skills & Knowledge:

• Professional presentation and conduct.
• Ability to prepare reports and communicate required actions to team members.
• Proficient in using Power BI to report against required outcomes.
• To have high levels of self-discipline, self-motivation, and energy.
• Intermediate to advanced knowledge of MS Office applications including Excel, PowerPoint, Outlook, and Word.

Ability to embrace DTI’s values.

Minimum 5 years experience

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2022 Gamuda Berhad (29579-T). All rights reserved.

Regular/Temporary: Permanent

Location: Petaling Jaya, 10, MY, 47820

The Quality and Assurance Engineer provides quality & completions assurance support to Australian projects within ACC from the Kuala Lumpur Gamuda Hub.

1. DTI Values
   - Work in accordance with DTI’s values and demonstrate commitment, active involvement and leadership regarding zero harm, client, people, and financial accountabilities.
2. Project Systems Support
   - Assist the Project Quality & Completions Manager/s to:
   - Develop the register of Project contract completions & handover requirements and track progress against deliverable development.
   - Assist project set-up in ACC and Gdos, including uploading the Work Breakdown Structure into ACC/Gdos and developing the project folder structure as required.
3. Project Quality Assurance
   - Conduct daily audits within ACC to ensure folders contain the required list of deliverables by the due dates.
   - Provide feedback and advice to the Project quality Team about the completeness of records within the ACC and DGos system.
   - Assist with the upload of records to the Gdos and ACC system.
4. Coaching and Training
   - Assist project team members to understand the functionality of ACC and Gdos.
   - Remain abreast of new features within ACC and Gdos and provide coaching to team members to ensure all are across relevant updates.
   - Provide coaching engineering teams to interpret reports to set quality and completions activity priorities on a weekly basis.
5. Reporting
   - Provide project reporting to assist the team to have visibility of the status of quality and completions records.
   - Provide input to project monthly reporting as required.

• Minimum: 5 years’ experience working as a professional engineer within the construction industry (preferably civil or structures).
• Minimum: Experience in using digital systems for the capture of construction quality documentation (as required by the ITP) in support of completions and handover.
• Minimum: Experience in the use of Power BI (or similar tool) to report against construction quality progress.

Preferred / Optional: Experience in checking the completeness of digital quality records in preparation for handover.

Experience:

• Ability to speak, write and understand the English language in relation to construction terminology.
• Ability to work independently and collaboratively in a dynamic environment.
• Ability to review and recommend opportunities for improvement, including gaps or new processes or to streamline transactional activities.

Ability to administer multiple and competing tasks concurrently.

Skills & Knowledge:

• Professional presentation and conduct.
• Ability to prepare reports and communicate required actions to team members.
• Proficient in using Power BI to report against required outcomes.
• To have high levels of self-discipline, self-motivation, and energy.
• Intermediate to advanced knowledge of MS Office applications including Excel, PowerPoint, Outlook, and Word.