DGM - QA Head(API)

Position: DGM – QA Head (API Manufacturing)
Reporting To: Quality Head

 

Role Summary

Lead the Quality Assurance function for the API manufacturing unit, ensuring compliance with global regulatory standards including US Food and Drug Administration (USFDA), European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), and World Health Organization (WHO) guidelines. Responsible for QMS, audit readiness, batch release, and overall quality governance of the plant.

Key Responsibilities



Lead and maintain cGMP-compliant Quality Management System (QMS) as per ICH Q7.


Handle regulatory and customer audits; ensure timely closure of observations.


Approve batch records, deviations, OOS/OOT, change controls, and CAPAs.


Oversee validation activities (process, cleaning, analytical methods, equipment).


Ensure data integrity and 21 CFR Part 11 complia...