DSP Supervisor
Date:
15 Jul 2025
Location:
Bangalore, KA, IN, 560099
Custom Field 1:
Manufacturing Services
- 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.