About this role
Job Description
- 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 3-7 years Education Post Graduation in Biotechnology or Life Science Graduation in Biotechnology or Life Science Competencies