Quality Compliance Manager (Pharmaceuticals)

Summary

• Work life balance
• Career Progression
• Attractive Package

Responsibilities

1. Develop and implement the factory’s quality strategy and objectives, ensuring a strong culture of compliance and safety across the entire organization.

2. Serve as the primary point of contact and official representative during inspections by regulatory bodies such as PIC/S, USFDA, and ASEAN.

3. Act as the custodian for the Quality Management System (QMS), overseeing change management, deviations, CAPA governance, and the supplier quality program.

4. Hold the final authority for product batch releases and maintain independent quality oversight to ensure all manufacturing meets safety standards.

5. Establish risk management frameworks (ICH Q9) and provide expert oversight on validation processes, including IQ, OQ, PQ, and cleaning validation.

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