QA Senior Specialist (Disposition)

Job Summary

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 ...