Senior Manager - QA Documentation

Roles & Responsibilities:
• Ensure overall QA compliance with cGMP, regulatory guidelines, and site SOPs
• Review and monitor quality systems and guide teams for implementation
• Review and approve BMR and BPR documents
• Prepare, review, and approve Media Fill protocols and reports
• Ensure compliance in cleaning, sterilization, and aseptic processes
• Oversee in-process QA activities and authorize finished product release/rejection
• Verify sampling activities and coordinate validation studies (process/cleaning validation)
• Approve commercial batch release to market
• Prepare, review, and implement SOPs and quality documents
• Assess and approve Change Controls, Deviations, CAPA, OOS, and investigations
• Implement systems for product complaints handling and product recall management
• Monitor environmental trends (Active, Passive, Surface & Personnel monitoring)
• Ensure batch documentation compliance as per cGMP
• Lead audit readiness activities and support internal/external audits
• Participate in management review meetings and drive continual improvement
• Prepare, review, and approve risk assessments for equipment, process, facility, and systems
• Provide oversight of validation activities across the shop floor
• Review and approve qualification/requalification protocols and reports
• Ensure accuracy of documentation before submission to Regulatory Affairs
• Review and approve commercialization artwork and maintain documentation traceability
• Perform additional responsibilities as assigned by the Head of Department
Qualification:
• Bachelor of Pharmacy (B.Pharm)
• Master of Pharmacy (M.Pharm)

Skills:
• cGMP & Regulatory Compliance
• Validation & Qualification Management
• Deviation, CAPA & Investigation Handling
• Documentation & Data Integrity
• Audit & Inspection Readiness
• Leadership & Team Coordination

About the Organization:
Amneal Pharmaceuticals is a leading global pharmaceutical company engaged in the development and manufacturing of high-quality generic and specialty medicines, with advanced oncology facilities and strong regulatory compliance standards worldwide.