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

Additional Responsibilities

QUALIFICATIONS

Education
B. Pharm B. Pharm - Required
M. Pharm M. Pharm - Preferred

Experience:
15 years or more in 15+ Years

Specialized Knowledge: Licenses:

📌 Deputy General Manager, Quality Control Ahmedabad
🏢 Amneal Pharmaceuticals
📍 Ahmedabad