Job Description
Essential Functions
JOB DESCRIPTION
- Lead Quality Control laboratory operations including analytical, microbiological, and stability testing
- Ensure compliance with cGMP and global regulatory standards for QC activities
- Oversee review, approval, and trending of analytical and microbiological data
- Govern OOS, OOT, deviations, investigations, and CAPA implementation
- Ensure effective instrument qualification (IQ/OQ/PQ), calibration, and maintenance
- Drive analytical method validation, verification, and transfer
- Oversee stability programs, shelf-life determination, and data review
- Lead audit and inspection readiness for internal, customer, and regulatory audits
- Manage supplier, material, and vendor quality testing and qualification
- Ensure data integrity, documentation control, and electronic system compliance
- Monitor QC performance metrics and continuous improvement initiatives
- Train, mentor, and develop QC teams and technical capabilities
- Review and approve SOPs, STPs, Specifications, Protocols, and Reports
- Implement laboratory efficiency improvement initiatives
QUALIFICATIONS
Education
- B. Pharm B. Pharm - Required
- M. Pharm M. Pharm - Preferred
- 15 years or more in 15+ Years
Job Details
| Role Level: | Not Applicable | Work Type: | Full-Time |
|---|---|---|---|
| Country: | India | City: | Ahmedabad ,Gujarat |
| Company Website: | http://www.amneal.com | Job Function: | Quality Assurance & Control |
| Company Industry/ Sector: |
Pharmaceutical Manufacturing | ||
What We Offer
About the Company
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