Responsible for overseeing timely and compliant disposition of GMP materials and products, ensuring adherence of critical quality attributes to applicable internal procedures and regulatory requirements.
Responsibilities - Review and approve GMP manufacturing batch records and related quality documentations.
- Responsible for ensuring all material qualification activities are completed and documented prior to use in GMP manufacturing.
- Approve or reject batches based on established specifications, SOPs and regulatory requirements.
- Collaborate with Procurement, QC, Warehouse and Manufacturing to maintain qualified supplier and material status.
- Collaborate with QA and manufacturing teams to resolve discrepancies, deviations, and CAPAs prior to disposition.
- Contribute to the establishment of an effective quality system and ensure its efficient operation across all GMP functions and processes in daily operations.
- Manage...