In-Process Quality Assurance (IPQA)
- Lead and manage IPQA activities for sterile/parenteral manufacturing operations including:
- Component preparation
- Compounding
- Filling and sealing
- Lyophilization
- Visual inspection
- Secondary packaging
- Ensure line clearance, batch startup checks, and in-process verification are performed as per approved procedures.
- Review and monitor critical process parameters during manufacturing and packing activities.
- Conduct routine shop-floor GMP audits and compliance checks. Aseptic Process Oversight
- Ensure adherence to aseptic techniques and contamination control strategies.
- Monitor aseptic interventions, media fills, and environmental monitoring trends.
- Participate in aseptic process simulations and investigations.
- Ensure proper gowning practices and personnel qualification compliance. Batch Documentation Review
- Review Batch Manufacturing Records (BMR), Batch Packing Records (BPR), and associated documents for completeness and compliance.
- Verify real-time documentation practices and data integrity compliance.
- Ensure timely review and closure of manufacturing-related records. Deviation, Investigation & CAPA Management
- Lead investigations for manufacturing deviations, OOS/OOT observations,



and market complaints related to sterile products.
- Perform root cause analysis using quality tools.
- Ensure effective implementation and monitoring of CAPA effectiveness.
- Track and review recurring quality issues and initiate preventive measures. Regulatory Compliance & Audits
- Ensure compliance with cGMP, Schedule M, WHO, EU GMP, MHRA, USFDA, and other applicable regulatory requirements.
- Support regulatory inspections and customer audits.
- Participate in audit responses and closure of observations.
- Drive quality culture and inspection readiness across manufacturing operations. Training & Team Management
- Lead, coach, and develop the IPQA team.
- Prepare training plans and conduct GMP, GDP, Data Integrity, and Quality System trainings.
- Evaluate team performance and identify development opportunities. Quality Systems Support
- Review SOPs, protocols, reports, risk assessments, and qualification documents.
- Support change control, validation, and qualification activities.
- Monitor quality metrics and prepare monthly quality reports.
- Participate in annual product quality review activities. Interested candidates can send resumes to [email protected]

📌 Sterile IPQA Manager (Guwahati)
🏢 SUN PHARMA
📍 Guwahati