Responsibilities

• Act as quality liaison during the shift operation, ensuring GMP compliance in all areas of operation, including Production, Warehouse, QC Laboratory and Facilities area.
• Advise teams on all aspects of GMP compliance and support the release of finished product release, assessing quality impact as necessary. Participate in on-line problems solving for quality issues, member of rapid response team in mitigating and resolving issues that arise during the shift.
• Conduct regular process confirmation gemba, driving quality compliance and quality culture at site.
• Serve as an Authorised Person (AP), reviewing batch records for completeness and accuracy. Ensure that retained samples are properly managed and batch production follows approved procedures and guidelines.
• Lead or involved as investigator or member of investigation team, to support Root Cause Analysis (RCA), Deviation investigations and Event Investigation.
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