SENIOR EXECUTIVE
- India
- Permanent
- Full-time
- Knowledge on operation of vial thaw, seed development bioreactors/ chromatography system, columns, TFF.
- Adherence to standard operating procedure operations.
- Support the manufacturing team and participate in shift operations. (Effectively operate Fermenter, Autoclave, Homogenizer, clean room equipment, cleaning tanks, centrifuges etc.
- Adherence to safety, Health and Environment measures.
- Updating, developing and implementation of quality and safety systems and ensure plant readiness for audit.
- Monitoring and control of specific production operations.
- Fermentation and chromatography operations and trouble shooting.
- Preparation of EHS documents related to production
- Filters integrity check
- Entering data in production records such as BMR's, checklists, Annexures, Attachments Log sheets.
- Calibration of weighing / PH/ Conductivity instruments in production.
- Product handling and packaging as per procedures.
- Basic knowledge of documentation for USFDA & EU
- Troubleshooting for upstream and downstream manufacturing process and equipment
- Clean room behaviour
- Knowledge on operation of vial thaw, seed development bioreactors/ chromatography system, columns, TFF.
- Adherence to standard operating procedure operations.
- Support the manufacturing team and participate in shift operations. (Effectively operate Fermenter, Autoclave, Homogenizer, clean room equipment, cleaning tanks, centrifuges etc.
- Adherence to safety, Health and Environment measures.
- Updating, developing and implementation of quality and safety systems and ensure plant readiness for audit.
- Monitoring and control of specific production operations.
- Fermentation and chromatography operations and trouble shooting.
- Preparation of EHS documents related to production
- Filters integrity check
- Entering data in production records such as BMR's, checklists, Annexures, Attachments Log sheets.
- Calibration of weighing / PH/ Conductivity instruments in production.
- Product handling and packaging as per procedures.
- Basic knowledge of documentation for USFDA & EU
- Troubleshooting for upstream and downstream manufacturing process and equipment
- Clean room behaviour
Required Experience: 3 - 6 years