- Assist in managing QMS documentation by drafting, routing for review, and safely archiving Standard Operating Procedures (SOPs) and quality manuals to ensure proper version control.
- Support the tracking of quality events by accurately logging deviations, Change Controls, and CAPAs (Corrective and Preventive Actions) into the system and monitoring them for timely closure.
- Help coordinate compliance training by organizing cGMP sessions for staff, updating training matrices, and ensuring all employee training records are current and audit-ready.
- Assist during internal and regulatory audits by promptly retrieving requested batch records, preparing compliance evidence, and supporting senior QA members in daily facility walkthroughs.
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