Assistant Manager / Deputy Manager - Analytical Quality Assurance

Key Responsibilities:
Manage all Analytical Quality Assurance (AQA) activities.
Review, approve, and close Quality Management System documents related to QC.
Act as Single Point of Contact (SPOC) for submission activities Dossier, Regulatory, Variation filings.
Handle customer communications related to QA.
Review manufacturing, packing, analytical reports of submission/validation batches.
Review Stability data and ensure submission compliance.
Ensure compliance of Stability Studies and Control Sample Handling at site.
Ensure adherence to GDP/GLP.
Monitor compliance of Gowning/De-gowning in QC lab.
Authorize written procedures, amendments, and related documentation.
Ensure SOP compliance across QC sections – RM/PM, FG, IP, AMV, PV, Stability, Tech Transfers, Microbiology, etc.
Verify real-time documentation and analytical logs.
Ensure logbooks and QC documentation are compliant and up-to-date.
Manage and ensure compliance of Quality Agreements.
Review and approve OOS/OOT, deviations, incidents, change controls.
Ensure QC lab is audit-ready at all times.
Oversee calibration, validation, maintenance, and qualification schedules.
Responsible for Finished Goods (FG) batch release in ERP.
Report and track safety near-misses/unsafe conditions.
Participate in EHS trainings and safety events.