Job Description
Job Description – Manager / Deputy Manager - QC (QMS)
Reports to: HOD – QC
Role Summary
Responsible for QC (QMS) activities in a biologics manufacturing facility ensuring compliance with cGMP and global regulatory standards (EMA, MHRA, ANVISA, SFDA, Health Canada).
Key Responsibilities
Review QC raw data, logbooks, test records, and CoA.
Ensure cGMP compliance through routine QC audits and inspections.
Handle QMS activities in TrackWise: Deviation, CAPA, Change Control, Incidents, OOS/OOT.
Ensure timely investigation, closure, and CAPA effectiveness tracking.
Review validation protocols/reports (method validation, verification, degradation studies).
Coordinate QC training on GMP, SOPs, investigations, and data integrity.
SOP preparation/review in SAP S/4 HANA.
Monitor environmental conditions (temperature & humidity) records.
Support internal/external audits and prepare compliance report...