Quality Assurance Engineer (Phamaceutical)
4000 - 6000 SGDFull-time
ALWAYSHIRED PTE. LTD.
As a Quality Assurance Specialist, you will play a critical role in ensuring compliance with regulatory standards and maintaining the highest quality standards in pharmaceutical operations.
Responsibilities:
- Review and approve master batch records, batch records, cleaning records, and procedures to ensure compliance with set standards.
- Ensure all GMP documentation adheres to quality procedures, regulatory requirements, and current Good Manufacturing Practices (cGMP).
- Review and approve deviations in accordance with site procedures.
- Handle product complaints, ensuring thorough investigations and implementation of effective Corrective and Preventive Actions (CAPAs) to prevent recurrence.
- Collaborate with cross-functional teams to prepare Annual Product Reviews, analyze trends, and recommend improvement actions for atypical observations.
- Apply Six Sigma, lean principles, and process improvement tools to drive continuous improvement in quality operations.
- Conduct internal and external audits to ensure compliance with regulatory standards.
- Maintain inspection readiness and support inspections from regulatory agencies and customers.
- Participate in GMP walkdowns to ensure site operations and facilities are maintained in an inspection-ready state.
- Support the maintenance of validated GMP systems and processes.
- Facilitate regulatory submissions and respond to regulatory queries in a timely manner.
Requirements:
- Bachelor’s Degree in Science, Chemical Engineering, or a related field.
- 1-3 years of relevant experience in QA/QC and GMP compliance within the pharmaceutical industry.
- Strong knowledge of GMP compliance regulations, ICH Q7a Guidelines, and Good Documentation Practices (GDP).
- Familiarity with manufacturing operations, Six Sigma, lean principles, and process improvement tools.
- Proven track record of driving continuous improvement in quality operations or manufacturing.
- Excellent attention to detail, problem-solving skills, and the ability to work collaboratively in a cross-functional team environment.
Interested candidates please apply online or send your latest CV to View email address on mycareersfuture.gov.sg
AlwaysHired Pte Ltd
Reg No: R1549345
EA: 24C2293
We regret to inform that only shortlisted candidates will be notified. Please note that your response to this advertisement will constitute informed consent to the collection, use, and/or disclosure of personal data by AlwaysHired, its affiliates and, where necessary, to relevant third parties, for purposes such as job application processing, career advisory, research, and other administrative purposes, in compliance with the relevant provisions of the Privacy Policy available at
Vacancy posted 13 days ago
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