Job Description
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
- Quality Systems & Documentation
- Change Control Management
- Vendor & Contract Management
- Validation & Qualification
- Batch Release & Compliance
6 Deviation, CAPA & Investigation
- Technology Transfer
- Customer & Regulatory Interfac
- Product Quality & Complaints Handling
- 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
Education
QUALIFICATIONS
Qualification: M.Sc. Chemistry
Experience
- 15 years or more in 15+ Years
