Job Description :
“The AGM – Quality Assurance is responsible for leading and ensuring compliance of all quality systems in API manufacturing, including documentation control, change management, validation, vendor qualification, batch release, regulatory coordination, deviation/CAPA management, and overall adherence to cGMP and customer requirements.”
Key Responsibilities:
1. Quality Systems & Documentation
2. Change Control Management
3. Vendor & Contract Management
4. Validation & Qualification
5. Batch Release & Compliance
6 Deviation, CAPA & Investigation
7. Technology Transfer
8. Customer & Regulatory Interfac
9. Product Quality & Complaints Handling
10.Quality Monitoring & Governance
Key Skills & Competencies
- Strong knowledge of cGMP, ICH, and regulatory guidelines
- Expertise in Quality Systems, Validation, and Compliance
- Hands-on experience in API manufacturing QA
- Strong analytical and problem-solving skills
- Leadership and team management abilities
- Audit handling (Regulatory & Customer)
- Excellent documentation and communication skills
Qualifications
Education:
Qualification: M.Sc. Chemistry
Experience:
- 15 years or more in 15+ Years