Job Title: Executive Quality Assurance (IPQA, Injectables)
Key Responsibilities
- Line Clearance & Area Release: Perform and issue rigorous line clearances before and during manufacturing and packaging activities to prevent cross-contamination. Verify the cleanliness of equipment, rooms, and status of materials.
- Aseptic Area Monitoring: Monitor critical environmental conditions (temperature, humidity, differential pressure) and particle counts in aseptic and cleanroom areas.
- Real-Time Process Monitoring: Oversee compounding, filtration, and aseptic filling operations. Ensure critical process parameters (CPPs) and critical quality attributes (CQAs) align with the Batch Manufacturing Record (BMR).
- Sampling: Withdraw in-process, finished product, retain, and stability samples according to established Standard Operating Procedures (SOPs).
- Documentation & Review: Review BMRs,
Batch Packaging Records (BPRs), equipment logbooks, and QC microbiological data in real-time. Ensure strict data integrity compliance across the plant
- QMS & Compliance Handling: Initiate and document deviations, change controls, and Corrective and Preventive Actions (CAPA) on the shop floor.
- Validation Support: Assist in process validations, media fills, and equipment/area qualifications.
- Educational Qualification: B. Pharm, M. Pharm, or M.Sc. (Microbiology/Biotechnology).
- Experience: 4to 8 years of relevant experience in QA/IPQA within a sterile/injectable pharmaceutical manufacturing plant.
NOTE: OLY MALES
Kindly share your updated resume to
[email protected] or whatsapp on (phone hidden)
📌 Ipqa Executive (Hyderabad)
🏢 Keybiz Dashboards
📍 Hyderabad