Officer/plant Operator

1 day ago

Ahmedabad Gujarat, India Zydus Group Full time

Department
- VTC Mfg - BVP
- Job posted on
- Feb 03, 2025
- Employment type
- P-P5-Probationer-R&D Staff

Operator Qualification - ITI/Intermediate ; Experience
- 5 to 8 years
- Responsible for maintenance of the equipment without any breakdowns.
- Experienced in handling of O-RABS, C-RABS, Isolators.
- Experienced in Ampoule/PFS/Vial/Catridges.
- Operation of Vial washing/ Filling/Lyophilizers/Autoclave/Process vessels.
- Adhere the aseptic behaviour to maintain GMP systems.
- To follow the instructions relating to production operations and to ensure their strict implementation.
- To ensure that vaccines are produced and stored according to the appropriate documentation in order to obtain the required quality.
- To ensure that the production records are evaluated and signed by an authorized person.
- Ensure compliance to Current Good Manufacturing Practices (cGMP)& documentation thereof for various production activities.
- To ensure the qualification and maintenance of department, premises and equipment.
- Ensure compliance to various In-process control guidelines provided in the batch documents.
- Ensure periodic preventive maintenance of plant and machineries as per schedule worked out by Engineering for optimum performance.
- Ensure that personnel follow basic safety guidelines during operations.

Officer - M.Pharm/B.Pharm/MSc/ B.Tech/M.Tech ; Experience
- 2 to 5 years
- Experienced in handling of O-RABS, C-RABS, Isolators.
- Experienced in Ampoule/PFS/Vial/Catridges.
- Operation of Vial washing/ Filling/Lyophilizers/Autoclave/Process vessels.
- To approve the instructions relating to production operations and to ensure their strict implementation.
- To ensure that vaccines are produced and stored according to the appropriate documentation in order to obtain the required quality.
- To ensure that the production records are evaluated and signed by an authorized person.
- Review investigation of Quality Management System (QMS) including market complaint, Out of Specification (OOS), change controls of manufacturing, risk assessment, Corrective Action and Preventive Action (CAPA) etc.
- Ensure compliance to Current Good Manufacturing Practices (cGMP)& documentation thereof for various production activities.
- To ensure the qualification and maintenance of department, premises and equipment.
- Ensure compliance to master formula and process provided in the Batch Manufacturing Record (BMR).
- To ensure that the appropriate validations are done.
- Ensure and manage manufacturing activities.
- Reviewing document like of Standard Operating Procedures (SOPs), Batch Manufacturing Record (BMR), Batch Packing Record (BPR), Master Formula Record (MFR)etc. and compliance reports thereof with training of personnel on the same.
- Ensure compliance to various In-process control guidelines provided in the batch documents.
- Ensure periodic preventive maintenance of plant and machineries as per schedule worked out by Engineering for optimum performance.
- Ensure that personnel follow basic safety guidelines during operations.

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