Quality Assurance Executive

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.