Job Summary:
We are seekinga proactive candidate to support and enhance the QMS through hands-on QAoperations and GMP compliance activities.
JobDescriptions:
- Maintain and continuously improve the QualityManagement System (QMS).
- Serve as the document controller for QualityManuals, Standard Operating Procedures (SOPs), Specifications, WorkInstructions, Forms, Records, and Quality Reports.
- Ensure compliance with GMP, PIC/S, ICH, ASEANGuidelines, FDA requirements, and other relevant regulatory standards.
- Manage and coordinate change controlactivities, including impact assessments, implementation, and timely closure.
- Support deviation investigations, perform rootcause analysis, and ensure effective implementation and closure of Correctiveand Preventive Actions (CAPA).
- Handle quality-related issues arising frommanufacturing operations and provide QA support to resolve compliance concerns.
- Prepare and review Annual Product QualityReview (APQR) reports and Management Review reports.
- Manage customer complaints, product recalls,product returns, and counterfeit investigations.
- Review and control packaging artwork,specifications, and technical drawings to ensure compliance with approvedrequirements.
- Provide QA oversight and support for equipmentqualifications, validation activities, machine testing, and trial runs.
- Monitor accelerated and real-time stabilityprogrammes.
- Promote and ensure adherence to GoodDocumentation Practices (GDP) and data integrity requirements.
- Participate in quality improvement initiativesand cross-functional projects related to quality systems and compliance.
- Support the implementation of electronicQuality Management Systems (eQMS).
- Perform any other duties assigned byManagement from time to time.
Job Requirements:
- Degree inPharmaceutical Science, Engineering, or a related field.
- Minimum 5 years of hands-on experience in QualityAssurance operations within the pharmaceutical, medical device, or regulatedmanufacturing industry.
- Strong knowledge of QMS (e.g. ISO 9001, cGMP) withhands-on experience in documentation control and implementation.
- Experience with eQMS will be an addedadvantage.
- Proven expertise in QA processes, includinginvestigations, change control, CAPA management, audits, and processvalidation.
- Meticulous, well-organised, and able to manage multiple prioritieseffectively.
- Excellent communication, interpersonal, and stakeholder managementskills.
- Proficient in Microsoft Officeapplications.
We regretthat only shortlisted candidates will be notified.
