- Handling of Deviations /Incidents /Non-conformance.
- Knowledge of investigation tools/certifications
- CAPA Management and effectiveness checks
- Hands-on experience on Vial washer, Tunnel, Filling Machine, Lyophilizer and Sealing machine
- Manufacturing Practices, Process Controls.
- Hands-on experience in Process & Cleaning Validations.
- Knowledge of Sterility Assurance Level and Contamination controls
- Quality Risk assessment for facility, equipment, and process.
- Change Control Management.
- Product quality reviews and corrective measures
- Trained Trainer
- Technical knowledge of Quality control testing.
- Material Management (Receipt, storage, dispensing and inventory of material)
- Calibration, Preventive maintenance, Breakdown management.
- Experience on the handling of TrackWise, LIMS, DMS, LMS
- Experience in the handling of manufacturing compliance activities like OOS, OOT, CAPA, Deviations.
Experience: 4-7 Yrs
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