Job Description
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Ensure readiness of equipment and instrument for process.
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Ensure availability of the process Raw materials, accessories and consumables in process area before batch execution.
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Preparation, Review of process, equipment and area related SOPs and EOP's.
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Preparation and execution of process, area and equipment qualification / validation protocols.
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Preparation of various reports like process, equipment, area qualification and validation.
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Preparation and Review of BPR.
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Request and Issuance of BPR.
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Preparation, Review and execution of study protocols.
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Readiness of downstream area and other areas like corridors and washing area etc. for manufacturing operations.
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To ensure smooth functioning of shop floor functions during manufacturing campaigns. To raise and review change control and deviations as per the requirement.
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Handling of SAP related activities like process and maintenance.
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Operating downstream equipment's for process and CIP/SIP.
11-16 Years
11 to 16 years of experience
M.Sc./B.Tech
Post Graduation
B.Tech in Biotechnology or Biochemistry
Biosimilar manufacturing, Production planning, QMS