DSP Operator

Syngene

2 - 4 years

4 - 6 Lacs

Bengaluru

Posted:6 hours ago| Platform:

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Skills Required

Procurement Process mapping Operational excellence Packaging Process development Manager Technology Management Operations Downstream Chromatography

Work Mode

Work from Office

Job Type

Full Time

Job Description

Execute and supervise 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 facilitys 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.

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