JobDescriptions:
- Maintain and continuously improve the QualityManagement System (QMS).
- Serve as the document controller for theQuality Manual, Standard Operating Procedures, Specifications, WorkInstructions, Forms, Charts, Records and Quality Reports.
- Ensure compliance with GMP, PIC/s, ICH, ASEANGuidelines, FDA, and other regulatory requirements.
- Prepare the annual Product Quality ReviewReport and Management Review Reports.
- Manage and follow up on change controls.
- Conduct process deviation investigations andfollow up on CAPA implementation for closure.
- Handle quality issues in manufacturingoperations.
- Manage customer complaints, product recalls,returns, and counterfeits cases.
- Review and control artwork anddrawings for packaging materials.
- Ensure machine testing, trial runs, qualifications, and validationmeet compliance requirements.
- Monitor accelerated and real-timestability programs.
- Ensure that Good Documentation Practices and traceability are in place.
- Undertake any additional tasks asassigned from time to time.
Job Requirements:
- Degree inPharmaceutical Science, Engineering, or a related field.
- At least 2 - 5 years of experience in quality assurancewithin the pharmaceuticals, manufacturing, or medical devices industries
- Strong knowledge of QMS (e.g. ISO 9001, cGMP) withhands-on experience in documentation control and implementation.
- Proven expertise in QA processes, includinginvestigations, change control, CAPA management, audits, and processvalidation.
- Excellent follow-up, communication, and interpersonal skills
- Meticulous and well-organised, and detail-oriented.
- Proficient in Microsoft Officeapplications.
We regretto inform you that only shortlisted candidates will be notified.
