Pune Biotech Manager Production MH

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

Biosimilar manufacturing, Production planning, QMS