Deputy Manager - Quality Control

Roles & Responsibilities:
• Manage overall Quality Control laboratory operations in compliance with cGMP and regulatory standards
• Plan and supervise preventive maintenance, calibration, and verification of QC instruments
• Ensure timely testing and release of raw materials, intermediates, and packing materials as per approved specifications
• Maintain strict adherence to GLP, GDP, safety protocols, and laboratory housekeeping standards
• Prepare and review stability protocols, monitor sample charging and withdrawal, and approve stability reports
• Oversee stability studies in line with regulatory guidelines
• Lead investigations for deviations, OOS, OOT, OOAL, and laboratory incidents; implement effective CAPA
• Review and approve QC-related change controls, SOPs, specifications, and analytical procedures
• Conduct audit trail reviews and ensure data integrity compliance for software-enabled instruments
• Oversee LIMS operations, ensuring accurate documentation, traceability, and regulatory compliance
• Ensure integrity, accuracy, and completeness of QC documentation and laboratory records
• Manage analytical column inventory, reference standards, and working standards as per SOPs
• Identify training needs and drive skill development initiatives for QC team members
• Support internal and external audits and maintain audit readiness

Qualification:
• M.Sc / Master of Pharmacy (M.Pharm) / Bachelor of Pharmacy (B.Pharm), (Chemistry or related discipline preferred)

Experience:
• 12+ years of experience in Quality Control operations within API manufacturing

Skills:
• Advanced knowledge of GLP & GDP compliance
• Strong expertise in Stability Study Management
• In-depth understanding of Data Integrity and LIMS operations
• Advanced experience in Deviation, OOS, OOT investigations and CAPA management
• Regulatory compliance and documentation review expertise
• Leadership, team management, and people development skills

About the Organization:
Amneal Pharmaceuticals is a global pharmaceutical company dedicated to developing, manufacturing, and distributing high-quality generic and specialty medicines. With advanced manufacturing facilities that meet international regulatory standards including USFDA and EU guidelines, the company emphasizes quality excellence, compliance, innovation, and continuous improvement across its operations worldwide.