1,130 Qa Specialist jobs in Singapore

Job Description

1. Provide expert consulting on designing, optimizing, and implementing global and U.S., specific quality management systems, ensuring alignment with alignment with industry best practices and regulations.

2. Support GCP - compliant software development/maintenance quality assurance, with a focus on meeting U.S. standards (e.g., FDA, ICH GCP).

3. Advise on internal audit planning, execution, and follow-up to align with U.S. regulatory expectations and identify process improvements.

4. Support U.S. market system certifications (e.g., ISO 13485, FDA21 CFR Part 11), including audit preparation and compliance.

5. Collaborate with cross-functional teams (R&D, Engineering, Product) to provide quality guidance, resolve compliance issues, and boost quality awareness.

Monitor U.S. regulatory updates (e.g., FDA guidelines, GCP changes) and deliver timely insights to stakeholders for ongoing compliance.

Working Location: Jurong Island

Working Hours: Monday - Friday, 8AM - 4.30PM

Company transport: Near Jurong East MRT Station

Responsibilities:

• Manage and maintain the organization's EVAL Quality Management System (QMS) to ensure compliance with ISO9001:2015, ISO14001:2015, and IATF16949 standards.
• Report QMS status and performance updates to site leadership on a regular basis.
• Oversee the Corrective Action Request (CAR) system to drive quality improvements and ensure compliance with industry and customer standards.
• Plan, manage, and support internal audits as well as third-party certification audits.
• Maintain accurate and up-to-date documentation for the Quality Management System.
• Coordinate timely responses to customer quality questionnaires.
• Lead and facilitate Root Cause Analysis (RCA) for quality issues and incidents.
• Collaborate with cross-functional teams to drive corrective actions and continuous improvements.

Requirements:

• Bachelor's degree in Engineering or a related field.
• Minimum 3 years of relevant experience in quality assurance within a manufacturing environment (including audits, CARs, and RCA).
• Solid knowledge of ISO9001, ISO14001, and IATF16949 standards and QMS practices.
• Trained and experienced in Root Cause Analysis methods.
• Strong facilitation and interpersonal skills to lead audits, investigations, and cross-team collaboration.

• Excellent written, verbal, and presentation skills, with proficiency in data analysis and reporting.

• Familiarity with FMEA or other risk analysis methods will be an added advantage.

• Experience with Power BI, document management, and workflow systems will be an added advantage.

We regret that only shortlisted candidates will be notified.

Interested applicants kindly click on "apply now" or send your updated resume to

Jayden Kua Jing Yu

Registration Number: R

EA License Number: 02C4944

People Profilers Pte Ltd, 20 Cecil St, #08-09, PLUS Building, Singapore

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

*QA Specialist (Senior/ Associate Principal) *

A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love.

That's what makes us Roche.

As a QA Specialist in the Quality Systems and Compliance department, you are responsible for providing quality oversight and managing all related activities in line with Roche policies, standards, procedures, and Global cGMPs. Your functional duties include managing regulatory inspections and corporate GMP audits, managing the internal inspection readiness program, and overseeing the systematic evaluation of new and emerging regulations. You'll also be responsible for supplier management, trending quality compliance performance, and acting as a regulatory liaison by addressing queries from Health Authorities and internal partners. Additionally, you will play a key role in  leading the execution and ongoing monitoring of Quality System elements, including Quality Management Systems (QMS), Annual Product Quality Review (APQR), Management Review of Quality (MRoQ), Quality metrics and Quality Risk Management (QRM).

*The Opportunity *

• Audit and Inspection Management: Oversee regulatory inspections, internal and external audits, and manage the site's self-inspection program to drive continuous improvement.
• Inspection Readiness: Develop and lead all site inspection readiness activities, including managing responses and mitigation plans for any observations.
• Compliance Risk Management: Manage the compliance risk program, keeping the site informed about new requirements and emerging trends.
• Supplier Quality: Support GxP supplier  management and collaborate with the Global Supplier Quality team to maintain GxP agreements.
• Regulatory Liaison: Act as a key liaison with PT Regulatory, coordinating between the site and PTR, and managing import and distribution licenses with affiliates.
• Quality Systems Oversight: Manage the site's Quality Systems program to ensure it's effective, efficient, and compliant with all relevant regulations.
• Risk Management: Oversee the risk management program to ensure potential product and patient risks are systematically assessed and documented.
• Continuous Improvement: Ensure the continuous improvement of the Quality Management System (QMS) processes, including the Site Master File, MRoQ, Quality Risk Management, and APQR.

*Who you are *

• Education and Experience: A degree in Science or Engineering with a minimum of five years of relevant experience in a pharmaceutical setting.
• Industry Knowledge: Strong understanding of Quality System principles, cGMP, and both local and international regulations, with a familiarity with Operations.
• Audit and Compliance Expertise: Proven knowledge of audit or inspection management and a strong analytical ability to interpret and apply quality standards.
• Leadership and Teamwork: A detail-oriented leader with excellent communication skills who can work both independently and collaboratively under pressure.
• Professional Skills: Demonstrated ability to make sound decisions, manage priorities, and build strong relationships to drive results.

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.

About the Role

We are hiring a QA Specialist for a leading pharmaceutical biologics client. This role offers an exciting opportunity to contribute to the assurance of quality standards in biologics manufacturing. The ideal candidate will bring 3+ years of experience in pharmaceutical quality assurance, with a strong emphasis on GMP compliance, batch record review, and regulatory readiness.

Key Responsibilities

• Batch Record Review (BMRs): Review and approve batch records, ensuring that all documentation is complete and accurate. Handle deviations and discrepancies, ensuring they are properly documented, investigated, and resolved.
• Deviation Management: Manage and investigate deviations, ensuring corrective and preventive actions (CAPA) are implemented to resolve quality issues.
• Change Control: Support and manage change control processes to ensure all changes are evaluated, documented, and approved in compliance with GMP requirements.
• Quality Systems & Compliance: Oversee quality systems activities such as cleaning validation, documentation reviews, and ensuring ongoing audit readiness.
• Regulatory Inspections: Support preparations for regulatory inspections (FDA, EMA, NPRA, etc.), ensuring all documentation and processes are in compliance with regulatory requirements.
• Data Integrity: Apply data integrity principles (ALCOA/ALCOA+) to maintain the reliability, completeness, and accuracy of all data within QA processes.

Requirements

• 3+ years of experience in a QA role within the pharmaceutical biologics industry, with hands-on experience in batch record review, deviation management, and CAPA processes.
• Strong understanding of GMP guidelines, quality systems, and compliance activities.
• Familiarity with regulatory inspections and experience in preparing for or supporting audits (FDA, EMA, NPRA, etc.).
• Knowledge of data integrity principles (ALCOA/ALCOA+) and demonstrated ability to apply them in QA operations.
• Excellent attention to detail with strong problem-solving skills and the ability to handle complex compliance challenges.

Responsibilities:

• Manage and maintain the Company quality management system compliance with designated management standards that include ISO , ISO and IATF14969
• Report the status of the Company quality management system to site leadership periodically
• Management of the corrective action request system to improve quality performance and ensure compliance with ISO9001, ISO14001 and IATF14969
• Schedule, manage and assist the internal audit program and third-party certification audits
• Maintain all documentation for the Quality Management System
• Manage timely response to Company customer quality management system questionnaires
• Facilitate formal Root Cause Analysis of quality and other incidents periodically
• Coordinate the corrective action request system to improve quality performance and ensure compliance with quality standards, customers, and organization's QMS.

Requirements:

• Bachelor's Degree in Engineering
• Minimum of 3 years of relevant experience in a manufacturing environment and quality assurance activities (Audits, CARs, RCA)
• Excellent working knowledge of relevant quality management standards (ISO9001, ISO14001, IATF16949) and related management systems
• Training and experience in utilization of Root Cause Analysis methods in a manufacturing environment

___

HOW TO APPLY :

Interested candidates, please submit your resume by clicking on "Quick Apply" or contact for more details.

Please provide following information in the resume for immediate processing

1) Reasons for leaving current and/or last employment

2) Last drawn and/or current salary

3) Expected salary

4) Date of availability and/or Notice Period

All applications will be treated in strictest confidence and only shortlisted candidates will be notified

Joni

EA License No : 03C5391

EA Reg No : R

KEY DUTIES AND RESPONSIBILITES:

• Preparation and review of qualification documents e.g., User requirement specification, DQ, IQ, OQ and PQ protocol for equipment, utilities & facility in compliance with the regulatory guidelines.
• Execution of qualification and validation activities including process, cleaning, computer system, equipment, utilities, and facility.
• Candidate must have knowledge and experience of qualification/validation principles and their practical application.
• Preparation and review of process and cleaning validation protocols and reports.
• Coordinate with the cross functional team and external service provider to meet qualification & validation schedules and maintain equipment, systems, and processes in validated state.
• Review equipment and process related change control; perform Risk Assessment to determine criticality of the proposed changes.
• Write, review, and revise validation SOPs in compliance with regulatory guidelines.
• QA oversight and/or review during the validation process.
• Manage incidents and deviations related to validation & qualification.
• Perform compliance reviews of all applicable deviations, investigations, and CAPAs related to qualification and validation.
• Review and suggest continuous improvements to the Validation Master Plan, current quality system practices, validation protocols and procedures for newly installed equipment, and overall validation strategies.
• Cross train and develop expertise in other areas of validation.
• Must be able to interact and lead effectively in a team-based environment.
• Familiarity with regulatory/compliance environment.

EDUCATION & EXPERIENCE

• Degree a scientific discipline or equivalent.
• Experience in a regulated industry preferred.
• Proficient in the use of Microsoft Word, Excel, Access, PowerPoint, and Explorer.
• A minimum of 5-7 years' relevant experience in pharmaceutical manufacturing environment.

We regret that only shortlisted candidates will be contacted.

Brief description:

To gather, analyse and report laboratory data from various AmSpec laboratory in the region. To assist the Singapore's Quality Department in the maintenance & promotion of the Company's Quality System.

Responsibilities:

• To gather and analyse laboratory data from various sources, including test results, instrument data, and quality control records.
• To evaluate data quality, identify potential issues, and implement corrective actions to ensure accuracy and reliability.
• To analyse data to identify trends, patterns, and potential areas for improvement in regional laboratory processes.
• To prepare reports and presentations summarizing data analysis findings and recommendations for improvement.
• To collaborate with Managers to implement process improvements based on data analysis findings.
• To provide training to laboratory staff on data analysis and quality control procedures for company's implemented system.
• To assist Chemists in identifying tests/equipment that requires SQC, gather necessary data, set up manual and electronic control chart. Monitor progress and ensure conformance.
• To assist the Quality Department in the maintenance & promotion of the Company's Quality Management System.
• To carry out calibration of general equipment in accordance to schedule.
• To assist in the preparation, compilation, and maintenance of Quality Manual of AmSpec Singapore which comply with standard for accreditation and requirements of the competent authority.
• To assist Laboratory Management Representative (MR), in conducting regular quality audits with the company and provide feedback to Department Manager.
• Ensure quality non-conformances are met with consistent follow-up
• To develop enhanced awareness with continual education of all AmSpec personnel on quality assurance principles and accreditation requirements. Regular in-house training, briefing, meeting and feedback dialogue session etc
• To work closely with Lab and business Manager in providing advice & and guidance in ensuring the consistently conform to Quality Assurance procedures.
• To deputize for the MR, in his / her absence in liaising with SAC-SINGLAS on all matters related to accreditation or other quality-related matters.
• To assist and implement necessary corrective actions assigned from all audits.
• To carry out internal and external calibrations and issue Certificate of Calibration based on the scope of accreditation.
• To undertake specific quality-related projects as directed by Regional Laboratory Manager.

Working Location: Jurong Island

Working Hours: Monday - Friday, 8AM - 4.30PM

Company transport: Near Jurong East MRT Station

Responsibilities:

• Manage and maintain the organization's EVAL Quality Management System (QMS) to ensure compliance with ISO9001:2015, ISO14001:2015, and IATF16949 standards.
• Report QMS status and performance updates to site leadership on a regular basis.
• Oversee the Corrective Action Request (CAR) system to drive quality improvements and ensure compliance with industry and customer standards.
• Plan, manage, and support internal audits as well as third-party certification audits.
• Maintain accurate and up-to-date documentation for the Quality Management System.
• Coordinate timely responses to customer quality questionnaires.
• Lead and facilitate Root Cause Analysis (RCA) for quality issues and incidents.
• Collaborate with cross-functional teams to drive corrective actions and continuous improvements.

Requirements:

• Bachelor's degree in Engineering or a related field.
• Minimum 3 years of relevant experience in quality assurance within a manufacturing environment (including audits, CARs, and RCA).
• Solid knowledge of ISO9001, ISO14001, and IATF16949 standards and QMS practices.
• Trained and experienced in Root Cause Analysis methods.
• Strong facilitation and interpersonal skills to lead audits, investigations, and cross-team collaboration.
• Excellent written, verbal, and presentation skills, with proficiency in data analysis and reporting.
• Familiarity with FMEA or other risk analysis methods will be an added advantage.
• Experience with Power BI, document management, and workflow systems will be an added advantage.

We regret that only shortlisted candidates will be notified.

Interested applicants kindly click on "apply now" or send your updated resume to

Jayden Kua Jing Yu

Registration Number: R

EA License Number: 02C4944

People Profilers Pte Ltd, 20 Cecil St, #08-09, PLUS Building, Singapore

About the Role
We are hiring a QA Specialist for a leading pharmaceutical biologics client. This role offers an exciting opportunity to contribute to the assurance of quality standards in biologics manufacturing. The ideal candidate will bring 3+ years of experience in pharmaceutical quality assurance, with a strong emphasis on GMP compliance, batch record review, and regulatory readiness.
Responsibilities
Batch Record Review (BMRs): Review and approve batch records, ensuring that all documentation is complete and accurate. Handle deviations and discrepancies, ensuring they are properly documented, investigated, and resolved.
Deviation Management: Manage and investigate deviations, ensuring corrective and preventive actions (CAPA) are implemented to resolve quality issues.
Change Control: Support and manage change control processes to ensure all changes are evaluated, documented, and approved in compliance with GMP requirements.
Quality Systems & Compliance: Oversee quality systems activities such as cleaning validation, documentation reviews, and ensuring ongoing audit readiness.
Regulatory Inspections: Support preparations for regulatory inspections (FDA, EMA, NPRA, etc.), ensuring all documentation and processes are in compliance with regulatory requirements.
Data Integrity: Apply data integrity principles (ALCOA/ALCOA+) to maintain the reliability, completeness, and accuracy of all data within QA processes.
Requirements
3+ years of experience in a QA role within the pharmaceutical biologics industry, with hands-on experience in batch record review, deviation management, and CAPA processes.
Strong understanding of GMP guidelines, quality systems, and compliance activities.
Familiarity with regulatory inspections and experience in preparing for or supporting audits (FDA, EMA, NPRA, etc.).
Knowledge of data integrity principles (ALCOA/ALCOA+) and demonstrated ability to apply them in QA operations.
Excellent attention to detail with strong problem-solving skills and the ability to handle complex compliance challenges.
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