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Description: Job Description - Ensure readiness of equipment and instrument for process. - Ensure availability of the process Raw materials, accessories and consumables in process area before batch execution. - Preparation, Review of process, equipment and area related SOPs and EOP's. - Preparation and execution of process, area and equipment qualification / validation protocols. - Preparation of various reports like process, equipment, area qualification and validation. - Preparation and Review of BPR. - Request and Issuance of BPR. - Preparation, Review and execution of study protocols. - Readiness of downstream area and other areas like corridors and washing area etc. for manufacturing operations. - To ensure smooth functioning of shop floor functions during manufacturing campaigns. To raise and review change control and deviations as per the requirement. - Handling of SAP related activities like process and maintenance. - 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