Posted:-1 days ago|
Platform:
Work from Office
Full Time
Responsible for dispensing, media / buffer preparation and execution of cell culture upstream/downstream processing in manufacturing area for commercial production, validations, engineering, clinical batches and related documentation.
Key Responsibilities:
• Dispensing of Raw materials and consumables as per BPCR.
• Responsible for general area cleanliness, sanitation, cGMP compliance of facility as per cGMP and SOPs.
• Execution of buffer preparation activities as per BPCR.
• Execution and processing of Upstream/Downstream operations for all commercial, engineering, clinical and validation batches as per production schedule.
• Documentation of batches as per SOPs and written procedures.
• Preparation & revision of equipment and process related SOPs, Protocols, Reports and any QMS documents as per current SOPs. Review of batch records, Formats, logbooks and other documents related to area of operation.
• Responsible for general area cleanliness, sanitation and compliance to bio safety policies.
• Qualification of new equipment’s, preparation and execution of Qualification documents (URS, DQ, IQ, OQ and PQ).
Intas
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