Sr. Manager/Manager - IPQA

Key Responsibilities

• Lead and oversee IPQA activities across sterile injectable manufacturing operations.
• Ensure QA oversight of aseptic filling, formulation, sterilization, visual inspection, packing and other manufacturing activities.
• Review and monitor BMR/BPR, logbooks, SOPs, protocols and other GMP documentation.
• Ensure compliance with cGMP requirements and approved procedures during manufacturing operations.
• Provide QA oversight for line clearance, area clearance, equipment status and batch manufacturing activities.
• Review and support investigation of deviations, incidents, OOS/OOT, market complaints and CAPA.
• Review and approve change controls, SOPs, specifications and manufacturing-related documents.
• Ensure effective implementation of environmental monitoring and aseptic practices in coordination with QC.
• Provide QA oversight for media fills / Aseptic Process Simulation (APS).
• Monitor Good Documentation Practices (GDP), data integrity and ALCOA+ compliance.
• Conduct routine GMP walkthroughs and shop-floor audits and ensure timely closure of observations.
• Support batch release activities by ensuring complete and compliant manufacturing documentation.
• Coordinate with Production, QC, Engineering, Validation, Warehouse and Regulatory Affairs.
• Lead regulatory inspection and customer audit readiness for IPQA-related activities.
• Identify GMP gaps and drive appropriate CAPA and continuous improvement initiatives.
• Develop, train and mentor the IPQA team and ensure effective manpower deployment.

Key Areas of Expertise

• Sterile Injectable / Aseptic Manufacturing
• In-Process Quality Assurance
• Aseptic Practices & GMP Compliance
• BMR/BPR Review
• Line & Area Clearance
• Environmental Monitoring
• Media Fill / APS Oversight
• Deviation, OOS/OOT & CAPA
• Change Control
• Data Integrity & ALCOA+
• Batch Documentation Review
• Regulatory & Customer Audits
• Shop-Floor GMP Compliance

Desired Profile

• 1218 years of experience in IPQA/QA, preferably in a sterile injectable manufacturing facility.
• Strong knowledge of USFDA, EU GMP, WHO GMP, Schedule M and ICH requirements.
• Proven experience in handling aseptic manufacturing operations and regulatory inspections.
• Strong understanding of GMP documentation, investigations, CAPA and change control.
• Excellent leadership, team-management and cross-functional coordination skills.
• Experience in new sterile injectable facility commissioning, product launch or technology transfer will be an advantage.