- Lead QA activities for API manufacturing operations.
- Ensure compliance with cGMP, WHO-GMP & regulatory requirements.
- Review and approve BMR/BPR, SOPs, specifications &
quality documents.
- Manage Deviations, CAPA, OOS/OOT & Change Controls.
- Oversee batch record review and product release activities.
- Ensure GMP compliance across manufacturing operations.
- Coordinate with Production, QC, R&D; & Warehouse teams.
- Handle internal, customer and regulatory audits.
- Review validation, qualification and quality-system documentation.
- Lead the QA team and drive continuous improvement in the