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 
