Job Descriptions:
- Maintain and continuously improve the Quality Management System (QMS).
- Serve as the document controller for the Quality Manual, Standard Operating Procedures, Specifications, Work Instructions, Forms, Charts, Records and Quality Reports.
- Ensure compliance with GMP, PIC/s, ICH, ASEAN Guidelines, FDA, and other regulatory requirements.
- Prepare the annual Product Quality Review Report and Management Review Reports.
- Manage and follow up on change controls.
- Conduct process deviation investigations and follow up on CAPA implementation for closure.
- Handle quality issues in manufacturing operations.
- Manage customer complaints, product recalls, returns, and counterfeits cases.
- Review and control artwork and drawings for packaging materials.
- Ensure machine testing, trial runs, qualifications, and validation meet compliance requirements.
- Monitor accelerated and real-time stability programs.
- Ensure that Good Documentation Practices and traceability are in place.
- Undertake any additional tasks as assigned from time to time.
Job Requirements:
- Degree in Pharmaceutical Science, Engineering, or a related field.
- At least 2 years of experience in quality assurance within the pharmaceuticals, manufacturing, or medical devices industries.
- Strong knowledge of QMS (e.g. ISO 9001, cGMP) with hands-on experience in documentation control and implementation.
- Proven expertise in QA processes, including investigations, change control, CAPA management, audits, and process validation.
- Excellent follow-up, communication, and interpersonal skills
- Meticulous and well-organised, and detail-oriented.
- Proficient in Microsoft Office applications.
Location: Macpherson Road
Working Hours: 5 days week (8.00am - 5.15pm)
