142 Pharmaceutical Qa jobs in Malaysia

Why Ansell?

At Ansell, we stay two steps ahead of workplace risk to deliver innovative safety solutions that enhance people's quality of life. As a global leader in protection solutions, we design and develop a wide range of products including gloves, clothing, and other protective gear to keep workers safe and productive across industrial, medical, and consumer applications.

Discover more about our company, our people, and our values by visiting us at Ansell .

Ansell is looking for a QA Specialist to join our team in Cyberjaya.

In this position you will play a vital role in Carry out QA activities as assigned in supporting organizational goals. This position will be responsible for onsite /virtual product inspection /audit, supplier audit, product sample evaluation and side by side comparison, and additional assignments such as multi-sources product evaluation and trending analysis, COA review, coordinating Change Control and implementation process, and/or as assigned by QA Manager and/or QARA Director.

What benefits and opportunities does Ansell offer?

• Competitive compensation plan, including a performance based annual incentive.

• Flexible and hybrid work model.

• A culture of belonging and inclusion, collaboration thrives, and everyone feels seen, heard, and empowered—across our global community.

• Ansell University, LinkedIn Learning and Mentorship programs to develop professional and interpersonal skills.

• Opportunities to advance and grow within the company through LinkedIn Learning and Mentorships.

What your role will be?

1. Onsite /virtual product inspection /surveillance /audit:
a. Perform product inspections and Quality audits of Ansell’s Manufacturing Partners.
The duties include:
b. Perform onsite /virtual inspection and testing of finished product to ensure
conformance to the agreed specifications, and maintain appropriate records.
c. The testing includes (but not limited to):
i. Water leak test
ii. Physical dimension measurements (length, width, thickness & weight)
iii. Physical properties measurements (Elongation, Modulus, Tensile Strength,
Force at break)
iv. Visual inspection (glove and packaging)
v. Packaging & labelling Quality
vi. Packing quality
vii. Glove durability test
viii. White residue /IPA and Foaming test
ix. Container loading (as needed)
x. Ash (filler check) to be performed by SA lab
xi. Etc. (as assigned by QA Manager /Director, from time to time)
d. Analyse test results of supplier’s Certificate of Analysis
e. Prepare trending charts for routine monitoring & conduct comparison analysis

f. Analyse test results and trends, and make comments and recommendations
g. Prepare inspection report and update quality dashboard
h. When necessary correlate localfactory test results with inhouse lab results and assist
in identifying and correcting unexplained data discrepancies
i. Identify production that deviates from historical trends, even if it still is within
specification
j. Work onsite with Manufacturing Partners to correct product quality and/or
manufacturing process related issues, including onsite verification of corrective
actions triggered from PQC/SCAR.
k. Work on special projects as needed

2. Supplier audit
a. Perform suppliers’ quality system audit and/or surveillance per ISO 9001, ISO13485,
US FDA 21 CFR 820 Quality System Regulation and Canada Medical Device Regulation
SOR/98-282.
b. Work with Manufacturing Partners to correct product quality and/or manufacturing
process related issues, including onsite verification of corrective actions triggered
from supplier audit finding.

3. Sample Evaluation
Assist in the product evaluation /qualification and set-up of new products and/or new
suppliers. Perform product testing, provide side by side product comparison reports, provide
analysis comments /recommendations, and highlighting product performance variation of new sourcing options or new potential products.

4. Sample Evaluation – multi-sources product
Assist in the product evaluation, comparison and trending analysis of multi-sources products. Perform product testing, provide side by side product comparison reports, provide analysis comments /recommendations, and highlighting product variation if any.

5. Change Control
Coordinate suppliers’ change request by initiating Change Control record in TWD, coordinate with PPM, RA, QA and MP to ensure the required aspects are carried out, reviewed and approved prior to implementation. Compile the necessary supporting test reports and documentation for CRB review /approval and carry out verification /effectiveness check of the change.

6. COA review
To review Certificate of Analysis (COA) as assigned, to ensure the shipment goods conforms to the product specification. Sign off COA and report OOS/OOC (if any) to QAM.

7. Other QA task(s) as assigned by QA Manager and/or Director.

What will you bring to Ansell?

• Bachelor Degree or equivalent collage education (in chemistry /polymer science) preferred; High School education accepted with sufficient work experience in QA, RA and QMS management.

• Working experience in Quality Management System (manufacturing) ISO9001, ISO13485 and MDSAP, US FDA QSR and CFR 21, and Supplier QARA Management Systems.

• Working experience in Medical Device QARA i.e. EN MDR and PPE regulations, all regional /country MD regulations including gloves standards i,e, ASTM, EN, ISO, JIS, TGA, GB & etc.

• Working experience in Glove manufacturing /Glove R&D preferred.

• Communicate fluently (oral & written) in English (required). Bahasa Malaysia (preferred), Chinese / Mandarin (preferred)

• Good written English with technical writing / reporting skills

• High Computer Literacy, specifically in MS Excel (particularly data trending and analysis), MS Word, MS PowerPoint, MS Access experience also preferred

• Analytical thinking and problem solving ability

• Ability to analyse & make comments /recommendations

• Able to work independently with minimal supervision

• Flexible in job rotation

Join us to lead the world to a safer future, apply today !

Equal Opportunity Employer

Ansell is committed to a policy of Equal Employment Opportunity and will not discriminate against an applicant or employee based on race, color, religion, creed, national origin or ancestry, sex, age, physical or mental disability, veteran or military status, genetic information, marital status, parental status, or any other legally recognized protected basis under federal, state, or local law. The information collected by this application is solely to determine suitability for employment, verify identity, and maintain employment statistics on applicants.

Our Commitment to Belonging and Inclusion

Ansell’s vision is about creating safe spaces where all perspectives are valued alongside individual contributions. When we say that everyone deserves to belong, feel included and empowered at work., it's not just words. We want applicants to know that we endeavor to create an inclusive environment that will consider all, regardless of age, gender, background, disability, veteran status, or experience alone! It’s what drives Ansell as an organization towards a workforce that reflects the communities in which we operate, it’s what drives us to serve our customers and stakeholders with pride, and it’s what differentiates Ansell.

At Ansell, we stay two steps ahead of workplace risk to deliver innovative safety solutions that enhance people's quality of life. As a global leader in protection solutions, we design and develop a wide range of products including gloves, clothing, and other protective gear to keep workers safe and productive across industrial, medical, and consumer applications.

Discover more about our company, our people, and our values by visiting us at Ansell.

Ansell is looking for a Specialist, Quality Assurance to join our team in Cyberjaya!

In this position you will play a vital role in carrying out QA activities supporting organizational goals, responsible for onsite/virtual product inspections, supplier audits, product evaluation, and analysis

What benefits and opportunities does Ansell offer?

• Competitive compensation plan, including a performance based annual incentive.
• Flexible and hybrid work model.
• A culture of belonging and inclusion, collaboration thrives, and everyone feels seen, heard, and empowered—across our global community.
• Ansell University, LinkedIn Learning and Mentorship programs to develop professional and interpersonal skills.
• Opportunities to advance and grow within the company through LinkedIn Learning and Mentorships.

What your role will be?

• Perform onsite/virtual product inspections and audits of Ansell's Manufacturing Partners
• Conduct testing of finished products for conformance to specifications
• Analyze test results, prepare trending charts, and make recommendations
• Identify and correct product quality and manufacturing process issues
• Perform supplier quality system audits per ISO standards
• Assist in product evaluation and qualification for new products
• Coordinate supplier change requests and implement change control
• Review Certificates of Analysis (COA) and report OOS results
• Perform other QA tasks as assigned

What will you bring to Ansell?

• Bachelor's degree or equivalent college (in chemistry/polymer science) preferred
• High School accepted with sufficient QA, RA, and QMS management
• 3-5 years experience in manufacturing with Quality Management Systems (ISO 9001, ISO 13485, MDSAP)//Medical Device QARA (EN MDR, PPE regulation)//Glove manufacturing/Glove R&D preferred
• The position requires frequent travel to multiple manufacturing locations throughout Malaysia, with occasional travel to Indonesia, China, Thailand, Vietnam & Sri Lanka.
• Data Trending and Analysis
• Technical Report Writing
• Microsoft Excel
• Microsoft Word
• Microsoft PowerPoint

Join us to lead the world to a safer future, apply today!

Equal Opportunity Employer

Ansell is committed to a policy of Equal Employment Opportunity and will not discriminate against an applicant or employee based on race, color, religion, creed, national origin or ancestry, sex, age, physical or mental disability, veteran or military status, genetic information, marital status, parental status, or any other legally recognized protected basis under federal, state, or local law. The information collected by this application is solely to determine suitability for employment, verify identity, and maintain employment statistics on applicants.

Our Commitment to Belonging and Inclusion

Ansell’s vision is about creating safe spaces where all perspectives are valued alongside individual contributions. When we say that everyone deserves to belong, feel included and empowered at work., it's not just words. We want applicants to know that we endeavor to create an inclusive environment that will consider all, regardless of age, gender, background, disability, veteran status, or experience alone! It’s what drives Ansell as an organization towards a workforce that reflects the communities in which we operate, it’s what drives us to serve our customers and stakeholders with pride, and it’s what differentiates Ansell.

Follow us on Instagram, Twitter, LinkedIn and Facebook.

• Seniority level Mid-Senior level

• Employment type Full-time

• Job function Research
• Industries Manufacturing

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Get notified about new Quality Assurance Specialist jobs in Cyberjaya, Selangor, Malaysia .

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Location : Moleac Pte Ltd Helios #09-08 11 Biopolis Way Singapore 138667

Employment Type : Full-time
Industry : Pharmaceutical / Health Products / Traditional Medicine
Experience Level : Mid-level (3–5 years)

About the Role

We are seeking a proactive and detail-oriented Quality Assurance (QA) Executive to join our team. The successful candidate will be responsible for supporting and monitoring the effective implementation and maintenance of quality systems, ensuring compliance with applicable GMP, GDP, and internal standards across all outsourced manufacturing and supply chain activities.

Key Responsibilities

• Plan and lead supplier audits for contract manufacturers and material suppliers as part of supplier qualification and periodic performance evaluations, in coordination with with relevant departments.
• Prepare and maintain quality agreement , documenting the defined roles and responsibilities of contract givers and contract acceptors in compliance with applicable GxP requirements, and conduct periodic reviews to ensure continued alignment and compliance.
• Develop, review, and maintain QA-related SOPs and documentation , covering areas such as contract activities management, supplier qualification and performance review, and Annual Product Review (APR).
• Maintain an organized and GDP -compliant documentation system , serving as a documentation controller to ensure traceability and regulatory readiness.
• Own and maintain the approved supplier and material list , ensuring updates reflect current qualification status and compliance with regulatory requirements.
• Participate in cross functional risk assessments , contributing to the identification and mitigation of quality and compliance risks.
• Plan and conduct self-inspections in accordance with GDP requirements to monitor internal compliance and drive continuous improvement.
• Support product complaints investigation and management, collaborating with the CMC team to ensure timely resolution and proper documentation.
• Coordinate with other departments on evaluation of deviation requests , ensuring risk and impact are properly assessed and documented.
• Propose and implement improvements to the Quality Management System (QMS) , ensuring alignment with evolving regulatory expectations and operational efficiency.
• Back-up for product release responsibilities :

1. Provide temporary or ad-hoc support to QC activities
2. Review and verify COAs, batch release documents, and laboratory records from Contract Testing Labs (CTLs).
3. Support coordination of sample submissions for raw materials, finished products, and stability testing to external labs, ensuring proper documentation and chain of custody.
4. Assist in investigating out-of-specification (OOS) and out-of-trend (OOT) results in collaboration with CTLs, ensuring timely escalation and documentation.
5. Monitor and track testing timelines to ensure timely release of products and materials.
6. Maintain and archive QC-related documentation in compliance with GDP standards.

Qualifications and Requirements

• Bachelor's degree in Pharmacy, Life Sciences or related field.
• Minimum 3 years of QA experience in pharmaceuticals or other health products industry.
• Good working knowledge of GMP, GDP or similar quality management system.
• Experience working with contract manufacturers is an advantage.
• Strong attention to detail and documentation accuracy.
• Good communication and coordination skills, especially across cross-functional teams.
• Ability to work independently and manage multiple tasks under stipulated timelines.
• Flexibility to travel overseas for business-related assignments including supplier audits.
• Excellent writing skill.
• Detail oriented, organized and proactive.
• Continuous Improvement mindset.
• Proficiency in written and spoken English and Chinese (for bilingual documentation & correspondence).

What We Offer

• A collaborative work environment committed to quality and regulatory excellence.
• Opportunities to gain exposure to regional and international markets.
• Competitive salary and benefits package.
• Career development and learning support.

Add expected salary to your profile for insights

Headquartered in Tokyo, Sumitomo Mitsui Banking Corporation (SMBC) is a leading global financial institution and a core member of Sumitomo Mitsui Financial Group (SMBC Group). Built upon our rich Japanese heritage since 1876, we put our customers first and provide seamless access to, from and within the Asia Pacific region. SMBC is one of the largest Japanese banks by assets and maintain strong credit ratings across our global integrated network. We work closely as one SMBC Group to offer personal, corporate and investment banking services to meet the needs of our customers.

With sustainability embedded within our strategy and operations, we are committed to creating a society in which today’s generation can enjoy economic prosperity and well-being, and pass it on to future generations.

Job Description

1. Review and to ensure that the audit engagements’ working papers are maintained and filed correctly in line with the standards of the Global Internal Audit Standards of The Institute of Internal Auditors and of the department.

2. Prepare Internal Quality Assurance Review report on quality reviews conducted.

3. Assist the Unit Head and Head of Internal Audit/ Chief Internal Auditor in the maintenance of the internal audit risk assessment and planning.

4. To ensure the proper maintenance of the department’s list of audit programs and list of regulatory policies and guidelines.

5. To ensure proper maintenance, monitoring and support of administrative activities over the internal audit function.

6. To manage a proper audit client effectiveness feedback evaluation process in maintaining the records and compiling the overall outcome to the Head of Internal Audit/ Chief Internal Auditor.

7. Perform other ad hoc assignments as may be assigned to them by the Unit Head and Head of Internal Audit/ Chief Internal Auditor.

Job Requisition

1. Degree or professional qualification in business, economics, accountancy, information technology or related discipline. Preferably possess the certification of a Certified Internal Auditor (CIA) from The Institute of Internal Auditors.

2. A member of The Institute of Internal Auditors/ Information Systems Audit and Control Association/ Asian Institute of Chartered Bankers or where relevant.

3. 8 years of banking related experience of which minimum 5 years of auditing or quality assurance review experience. Have a good understanding of the Global Internal Audit Standards of The Institute of Internal Auditors.

4. Strong leadership skills.

5. Strong in administration and management skills.

6. Strong motivator with people influential skills.

7. Good interpersonal skills.

8. Good writing and articulation skills.

9. Have a probing, inquisitive, conceptual and analytical mind.

10. Meticulous and an eye for details.

11. Ethically strong towards to the profession of auditing in upholding independence and objectivity.

Salary match Number of applicants Skills match

Sumitomo Mitsui Banking Corporation (SMBC) operates globally with extensive overseas branches that offers a broad range of financial services. Due to its incorporation of a wholly owned subsidiary in Malaysia, SMBC is now inviting you to be part of its talent pool where you can grow with us. This is indeed a good opportunity for you to chart your career collaboratively with SMBC to greater heights.

Sumitomo Mitsui Banking Corporation (SMBC) operates globally with extensive overseas branches that offers a broad range of financial services. Due to its incorporation of a wholly owned subsidiary in Malaysia, SMBC is now inviting you to be part of its talent pool where you can grow with us. This is indeed a good opportunity for you to chart your career collaboratively with SMBC to greater heights.

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• Strong understanding of quality assurance principles
• Experience in quality control processes and procedures
• Ability to conduct quality audits and develop quality standards
• Knowledge of regulatory requirements and industry standards
• Attention to detail and analytical skills
• Excellent communication and interpersonal skills
• Quality assurance certification is a plus
• Bachelor's degree in Engineering or related field

Job Description:

• Organize the formulation of quality management documents and quality technical regulations, guide and supervise the implementation of documents, and inspect, correct and continuously improve the implementation of quality management documents;
• Responsible for the establishment of raw material inspection, production process and product quality control system, formulate and improve product inspection standards and test standards;
• Formulate annual verification plan, approve production process verification, lead the completion of test method verification and daily quality monitoring activities;
• Statistical analysis of quality abnormalities, follow up on sudden abnormal situations;
• Have the right to stop production activities to correct quality problems;
• Participate in the implementation of product material design or process change process, and continuously improve the quality level of process and product;
• Responsible for coordinating the work between the quality management department and various departments in accordance with the requirements of the quality manual and procedure documents;
• Responsible for coordinating with relevant departments for customer factory inspection;
• Accept other work assigned by manager.

Requirements:

• College degree or above
• More than 3 years of quality work experience
• Familiar with the laws, regulations, government policies, and standards and specifications that the company's products are adapted to;
• Good organizational coordination, judgment, communication, planning and execution skills;
• Familiar with product process validation, new product validation process and methods;
• Hardworking, responsible, and no bad record;

Position Title : Quality Assurance Executive

Workbase: Cheng, Melaka

Key Responsibilities:

• Provides support Quality Management System operation, including change control, deviation, customer complaint, recall, CAPA management;
• Support annual product quality review;
• Support the investigation to non-conformance;
• Support stability study management;
• Review and approval of protocols and reports of qualification & validation, including equipment qualification, utilities qualification, analytical method validation, process validation, cleaning validation and so on;
• Support on computerized system validation and implement GAMP5 requirement;
• Support the implementation of Good Distribution Practice and Good Warehouse Practice;
• Implement quality risk management;
• Support on product toxicity assessment;
• Support and provide QA oversight on good laboratory practice compliance;
• Support on plant wide audit trail review.;
• Propose and execute quality improvement program;
• Lead and coordinate projects and manage the deliverables effectively;
• Develop skills to front auditors as SME/ supporting QA oversight;
• Support in Supplier Quality Management System
• Governance of Pest Control/ Environmental Monitoring

Minimum Requirements:

• Degree in Pharmacy with minimum two years working experience, degree in Chemistry, Microbiology, Science or Engineering, with minimum two years (QA Executive II) and three years (QA Executive I) in the quality assurance, quality control or related functions in a manufacturing operation.
• Experience in the management of Quality Assurance Programs for pharmaceutical and prior statistical background will be an added advantage.
• Good knowledge of ISO and PIC/S regulations and cGMP is required.
• Excellent interpersonal and communication skills (speaking and writing in English) and able to work independently.
• Attention to detail, possess planning and organizing skills, critical thinking skills, judgment skills and decision-making skills.
• Proficient in Microsoft office applications.

• Lead and govern QA operations across incoming, production, reliability and product quality, excursion, QA inventory controls, ensuring consistency, accuracy, and quality compliance.
• Detail-oriented and proactive individual to manage quality excursions and oversee inventory operations at manufacturing facility.
• Responsible for identifying, containing, and resolving quality issues while ensuring accurate inventory control and efficient material flow.
• Monitor and investigate in-line and post-production quality excursions and operations.
• Coordinate cross-functional teams to perform root cause analysis and implement corrective and preventive actions (CAPA).
• Verify effectiveness of corrective and preventive actions taken.
• Lead containment activities for defective or suspect materials and ensure appropriate disposition.
• Maintain quality excursion logs and generate regular reports for internal stakeholders.
• Collaborate with engineering, production, and quality assurance teams to resolve process issues and drive continuous improvement.
• Perform regular inventory audits and reconciliations to maintain accuracy.
• Track inventory movement and conduct regular stock reconciliations.
• Conduct periodic physical inventory counts and cycle counts; investigate and resolve discrepancies.
• Maintain accurate inventory records including product location, batch/lot numbers, and shelf life (if applicable).
• Ensure compliance with safety and quality standards in all inventory-related operations.
• Responsible & accountable for Process Quality Excursion (QAx & SSx)
• Oversee daily quality control processes to ensure quality of final products meets customer’s expectations.
• Support and conduct internal and external audit activities related to process
• Facilitate resolution of proactive quality initiatives; continuous improvement, preventive actions & mistake proofing
• Develop Statistical process control (SPC) system set up (mechanism), including control limits setting, response rules, triggering feature and ensure out of control action plan is followed.
• Develop, conduct & ensure effectiveness of pFMEA, OFE and OCAP
• Create, review update and ensure standard operation procedure (SOP), inspection checklist, control and OCAP plan are being met.
• Responsible for new process, line and tool buy off/readiness and qualification.
• CCB & deviation evaluation verification on Process Related.
• Involve 8D & Lesson learned on Process Related Issue
• Responsible for RMA & FA process relate issue for root cause analysis & Improvement plan.
  
  

• Manage the performance of the process control team by setting clear goals, regularly reviewing performance, and providing feedback to drive continuous improvement.
• Identify development opportunities and implement training programs to enhance team skills and capabilities.
• Foster a positive work environment by encouraging collaboration, innovation, and open communication.
• Mentor and guide team members in their career development, aligning their growth with organizational objectives.
• Handle recruitment, onboarding, and performance appraisals, ensuring alignment with the organization’s talent management strategies.
  
  

• Bachelor or master degree in electronics, or Science related with 5+ years working experience.
• Experience – minimum of 5 years' experience in manufacturing quality management and PCBA manufactruing industry.
• Experience managing a team of process control or operations analysts.
• Demonstrated ability in performance management, talent development, and team leadership.
  
  

• Strong knowledge of process FMEA, SOP management, and audit processes.
• Experience with business contingency planning and IMS implementations.
  
  

• Strong problem-solving skills with a structured approach to diagnosing and resolving issues.
• Proven experience in driving 6S program implementation and compliance.
• Strong organizational skills and strategic thinking.
• Excellent communication and leadership skills with strong stakeholder management.
• Results-oriented with a proactive leadership style focused on continuous improvement and operational excellence.
  
  

• Conduct evaluations of Call Center and Customer Service interactions to ensure adherence to quality standards.
• Implement and maintain Quality Assurance processes and protocols.
• Evaluate the performance of Call Center and Customer Service representatives based on established criteria.
• Provide constructive feedback to enhance performance.
• Utilize basic Excel analysis skills to review and analyze performance data.
• Prepare reports on Quality Assurance findings and performance metrics.
• Communicate effectively with different stakeholders, including Call Center representatives and management.
• Provide training and support to improve performance.
• Identify areas for improvement in Call Center and Customer Service processes.
• Collaborate with relevant teams to implement process enhancements.
• Maintain accurate records of Quality Assurance evaluations and performance data.
• Ensure compliance with documentation standards.
  
  

• Proven experience dealing with Call Center and Customer Service Performance Evaluation.
• Previous experience in Quality Assurance is highly preferred.
• Proficiency in basic Excel analysis for data review and reporting.
• Ability to communicate effectively with stakeholders.
• Proficiency in Mandarin or Thai languages is highly preferred.
• Detail-oriented approach to ensure accuracy in evaluations and documentation.