Deputy General Manager, Quality Control

Amneal Pharmaceuticals

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:

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