Officer - Production Mammalian

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 1-4 years

Education Post Graduation Graduation in Biotechnology or Life Science

Competencies