Assistant Manager - Quality Assurance

Roles & Responsibilities:
• Ensure compliance with cGMP and regulatory requirements on manufacturing and packaging shop floor
• Perform real-time in-process quality assurance (IPQA) activities for injectable products
• Supervise dispensing activities in manufacturing and packing areas
• Provide machine and area clearance prior to batch execution
• Conduct sampling of in-process, reserve, and stability samples as per BPR and stability protocols
• Perform online review of documents including batch records, equipment logbooks, calibration records, environmental monitoring records, and housekeeping logs
• Calibrate IPQA instruments as per schedule
• Review and release batches after ensuring compliance with quality standards
• Review in-process and finished product COA prior to batch release
• Monitor aseptic behavior and GMP practices of operators during aseptic processing
• Participate in investigations (deviations, OOS, OOT) and support root cause analysis
• Ensure audit readiness by maintaining IPQA documentation
• Provide on-the-job GMP and documentation training to shop floor personnel

Qualification:
• Bachelor of Pharmacy (B.Pharm)
• Master of Pharmacy (M.Pharm), M.Sc

Experience:
• 8–12 years of experience in IPQA within Injectable pharmaceutical manufacturing

Skills:
• Strong knowledge of cGMP and regulatory requirements
• Experience in aseptic area monitoring and injectable manufacturing
• Good documentation review and batch release knowledge
• Investigation handling and compliance reporting skills
• Strong written and verbal communication skills in English
• Audit readiness and regulatory compliance focus

About the Organization:
Amneal Pharmaceuticals is a global pharmaceutical company committed to delivering high-quality, affordable medicines. With a strong presence in generic and specialty pharmaceuticals, Amneal operates state-of-the-art manufacturing facilities that comply with international regulatory standards including USFDA, EU, and other global health authorities. The company focuses on innovation, quality excellence, and patient-centric healthcare solutions, serving markets across the United States, India, and several international regions.