Production Executive-Upstream Cell culture Job at Syngene

Syngene is hiring for the role of Production Executive-Upstream Cell culture!

Responsibilities of the Candidate:

• Ensure there is no violation of any environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety.
• Escalate safety related incident through appropriate channel.
• Wear all required PPE at all times.
• Understand and demonstrate that you are responsible for safety of self & colleagues by following all necessary safety protocols at all times.
• Identify near-misses and potential incidents proactively and communicate those.
• Attend all assigned mandatory trainings related to upstream, data integrity, health, and safety measures.
• Follow the discipline of reporting structure at times of escalation.
• Compliance to Current Good Manufacturing Practices
• Adherence to Standard Operating procedures, Operational control Procedures
• Perform all the upstream activities like Assembly preparation, Media Preparation, Vial thaw, Feed preparation and Filtration, Bioreactor Operations to Batch Harvest.
• Monitoring and process control of the specific Operations of the Upstream.
• Maintenance of Quality records.
• Traceability from Raw material till finished Product.
• In-process product Sampling and storage
• Preparation and review of Operation related Documents
• Perform room owner responsibility for the assigned USP area
• Perform equipment/Instrument ownership related responsibilities related to USP
• Initiate Complaint Slips (work orders) for USP related areas and equipment.
• Coordinate with QA for Line Clearance
• LNS System monitoring and LN2 tank refilling
• Gas Bank Monitoring
• Following good Aseptic behavior inside BMP1 Facility
• Maintaining process area All-time ready for Inspection / Audit purpose.
• Preparation of general upstream related procedures, Protocols, Risk assessment and BMRs.
• Execution of protocols related to upstream related activity and equipment / instrument qualification.
• General consumable stock review and record maintenance
• Ensure PM planner and calibration planner are followed.
• Execution of batch activity as per BMR and report non-conformity to the supervisor.
• Issuance of annexures, RM, consumables and BMRs.
• Tracking of work order status and ensuring timely closure.

Requirements:

• M.Sc/B.Tech(1-3 years) of relevant experience