Job Description

• Execute and supervise BMP4 batch activities in accordance with BMRs and established protocols.
• Prepare, revise, execute, and review Batch Manufacturing Records (BMRs)/PDR/SOPs/Protocols
• Having strong knowledge of Chromatography techniques, UFDF, Column packing-unpacking.
• Should be well versed with continuous centrifugation, Homogenizer, and single-use technology.
• Collaborate with Process Development, MSAT, and Operational Excellence teams for process scale-up and technology transfer activities.
• Prepare and review qualification documents as per SOPs, ensuring timely review and approval with cross-functional teams.
• Execution of Installation, Operational, and Performance Qualification (IQ/OQ/PQ) for downstream equipment.
• Coordinate Commissioning & Qualification activities through collaboration with internal and external cross-functional teams and subject matter experts (SMEs).
• Coordinate with the maintenance department for the upkeep of operational equipment.
• Ensure all operational documents, batch records, and checklists are compliant with cGMP
• Should have good knowledge about process mapping and equipment mapping as per project requirements.
• Coordination with the client for finalization of process requirements and address client quarries related to project.
• Manage the stock of required consumables for batch activities and ensure timely procurement.
• Prepare and review quality protocols and investigate any batch failures in operations.
• Support the facility's readiness for regulatory inspections.
• Having strong knowledge of QMS activities (Change Control, Deviation, CAPA, Investigation, etc.)
• Report deviations and manage change controls, collaborating with QA to implement corrective actions.
• Carry out additional tasks as assigned by the HOD.