Job Title: Sr. Executive - BBM
Purpose of Job
Responsible for execution/planning of upstream processing of cell culture based products in manufacturing area for commercial production, validations, testing and related documentation
Roles and Responsibilites
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Execute and manage cell culture operations for all commercial, test, and validation batches according to the production schedule.
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Maintain accurate and complete batch documentation in compliance with SOPs and written procedures.
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Ensure strict adherence to cGMP standards in the cell culture area as per BBM SOPs.
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Prepare and revise SOPs related to equipment and processes within the cell culture area.
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Maintain general cleanliness, sanitation, and compliance with biosafety policies in the cell culture facility.
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Manage media preparation activities integral to cell culture operations.
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Compile documentation related to raw materials and consumables used in the cell culture process.
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Oversee qualification of new equipment, including preparation of qualification documents (URS, DQ, IQ, OQ, PQ).
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Compile data and update operational trends for continuous monitoring.
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Provide authorization for batch initiation as per defined responsibilities.
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Act as designee in the absence of Cell Culture Assistant Manager, Manager, and Shift In-Charge.
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Authorize QMS initiation and provide department head comments within Q-edge QMS software.
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Adhere to ‘Good Documentation Practices’ and Data Integrity requirements during all GxP operations and site recordings.
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Ensure understanding and application of Data Integrity requirements, emphasizing the consequences of non-compliance.
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Review GxP data (records, reports) from a compliance perspective related to Data Integrity as relevant to the role.
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Manage and address any potential data breaches in accordance with the SOP on ‘Handling of Potential Data Integrity Observation’.
Biotech, Ahmedabad, GJ, IN, 382213