Assistant Manager IPQA

Essential Functions:

JOB DESCRIPTION

• Take regular plant rounds to monitor production activities and ensure cGMP compliance at the shop floor level.
• Review and approve Batch Manufacturing Records (BMR), Batch Cleaning Records (BCR), and related analytical records prior to release of API.
• Prepare and revise SOPs, BMRs, BCRs, BPRs, and other QA-related documents in line with regulatory and internal requirements.
• Perform sampling of APIs, maintain related records, and ensure proper cleaning and maintenance of sampling tools.
• Maintain records and storage of control samples of API as per defined procedures.
• Provide line clearance at every product changeover stage, ensuring readiness of area and equipment.
• Monitor dispatch process and review records related to finished goods dispatch to ensure compliance.
• Coordinate and support investigations of deviations, incidents, and non-conformances with QA Head/Designee.
• Participate in Product Quality Reviews (PQR) for all APIs, compiling relevant data and identifying improvement areas.
• Monitor process and cleaning validation activities on the shop floor to ensure compliance with protocols.
• Support data integrity, documentation practices, and readiness for internal/external audits.
• Coordinate with production, QC, engineering, and warehouse teams for day-to-day IPQA requirements.
  
  

• Participate in risk assessments (HIRA), change controls, and CAPA implementation related to IPQA.
• Support training of QA executives and production personnel in cGMP, documentation, and in-process control requirements.
• Assist in handling of quality events such as market complaints, recalls, and audit observations.
• Contribute to continuous improvement initiatives within QA and across departments.
• Ensure readiness and compliance for regulatory inspections and internal quality audits.
• Lead initiatives related to QMS enhancements and harmonization of documentation practices.
• Maintain logs, registers, and master data related to IPQA activities.
• Monitor and report compliance KPIs to QA management.
• Act as QA representative in daily production meetings and batch release discussions.
  
  

• B.Sc – Organic Chemistry – Required
• M.Sc – Organic Chemistry – Preferred
• B.Pharm / M.Pharm – Preferred
  
  

• 8 to 10 years of relevant experience in IPQA within an API manufacturing environment.
  
  

• IPQA & Line Clearance Activities – Advanced
• Batch Documentation Review (BMR, BCR, BPR) – Advanced
• Process & Cleaning Validation Oversight – Intermediate to Advanced
• Deviation/Incident Investigation – Intermediate
• Control Sample & Sampling Procedures – Intermediate
• cGMP & Data Integrity Compliance – Advanced
• QMS Documentation & SOP Preparation – Intermediate
• Product Quality Review (PQR) – Intermediate
• Shop Floor Quality Monitoring – Advanced
• Cross-functional Communication & Coordination – Intermediate to Advanced.
  
  

• B.Sc – Organic Chemistry – Required
• M.Sc – Organic Chemistry – Preferred
• B.Pharm / M.Pharm – Preferred