DGM QA Head(API)
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Job Location:
Monthly Salary:
Posted on:
3 hours ago
Vacancies:
1 Vacancy
Job Summary
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 compliance.
Drive quality culture and continuous improvement initiatives.
Qualifications & Experience
./ (Pharmaceuticals/Chemistry).
15 years in API manufacturing with 5 years in QA leadership role.
Strong experience in handling USFDA/EU regulatory inspections.
Key Skills
- Graduate Engineering
- Corporate Risk Management
- Adobe Photoshop
- Big Data
- Clinical
- Asic
