Officer - Production Mammalian

• Responsible for manufacturing operations related to upstream of Mammalian Manufacturing facility.
• Preparation and review of GMP documents like SOPs, BPRs, qualification and validation protocols, technology transfer documents and other process or facility related documents for media preparation and cell culture operations.
• Execution of disposable bioreactor, SS bioreactors and glass bioreactors operations as per written procedure.
• Execution of media fill inoculum transfer and subculture operations as per written procedure.
• Responsible for execution of media preparation, CIP and SIP of bioreactors, cell culture and cell banking operations as per written procedures.
• In-process recording of process parameters and In-process sample analysis for media preparation and cell culture operations.
• Maintenance of facility and equipment related to media preparation operations, cell culture operations and cell banking operations.
• Co-ordinate with QC, QA, Engineering, WH, MSAT and R&D departments.
• Execution of qualification activities related to equipment and process.
• Preparation of documents related to tech transfer and scale up of process. Participate in tech transfer and scale up of process.
• Preparation, execution & maintenance of SOP’s, BPRs, qualification documents and other facility related documents i.e. URS.
• Responsible for all production related SAP transaction.
• Plan and execute operations related to process characterization & process validation.
• Review of executed BPR’s and protocols, logbooks, annexures, checklist and other essential cGMP documents.
• Planning and facing of internal as well as external audits/visits as per business requirement.
• Deviation identification and investigation assistance for the facility related deviations
• Routine monitoring of facility and record maintenance e.g. temperature, humidity, differential pressure. To assist in facility validation in coordination with QA.
• Routine environmental monitoring, record maintenance and co-ordination with engineering and QC department for smooth facility maintenance.
• Overall housekeeping management.
• To assist in facility validation in coordination with QA.
• Any responsibility advised by the superior from time to time.
• To comply with the current & subsequent EHS management system, procedures, guideline, policy, practices, requirement and applicable legal compliances on site.

Work Experience

0-2 year

Education

Competencies