Job Title: Officer - BBM
Purpose of Job
Responsible for dispensing, media / buffer preparation and execution of cell culture upstream processing in manufacturing area for commercial production, validations, engineering, clinical batches and related documentation.
Skill Required
- Dispensing of Raw materials and consumables as per BPCR.
- Responsible for general area cleanliness, sanitation, cGMP compliance of facility as per cGMP and SOPs.
- Execution of media preparation activities as per BPCR.
- Execution and processing of cell culture operations for all commercial, test and validation batches as per production schedule.
- Documentation of batches as per SOPs and written procedures.
- Preparation & revision of equipment and process related SOPs as per current operations.
- Responsible for general area cleanliness, sanitation and compliance to bio safety policies.
- Qualification of new equipment’s, preparation and execution of Qualification documents (URS, DQ, IQ, OQ and PQ).
- Responsible for execution of equipment’s PV and ensuring proper preventive maintenance of equipment’s.
- Data compilation and trend updation.
Roles and Responsibilites
- Dispensing of Raw materials and consumables as per BPCR.
- Responsible for general area cleanliness, sanitation, cGMP compliance of facility as per cGMP and SOPs.
- Execution of media preparation activities as per BPCR.
- Execution and processing of cell culture operations for all commercial, test and validation batches as per production schedule.
- Documentation of batches as per SOPs and written procedures.
- Preparation & revision of equipment and process related SOPs as per current operations.
- Responsible for general area cleanliness, sanitation and compliance to bio safety policies.
- Qualification of new equipment’s, preparation and execution of Qualification documents (URS, DQ, IQ, OQ and PQ).
- Responsible for execution of equipment’s PV and ensuring proper preventive maintenance of equipment’s.
- Data compilation and trend updation.
Qualification Required
MSc or M.Tech
Relevant skills / Industry experience
- Dispensing of Raw materials and consumables as per BPCR.
- Responsible for general area cleanliness, sanitation, cGMP compliance of facility as per cGMP and SOPs.
- Execution of media preparation activities as per BPCR.
- Execution and processing of cell culture operations for all commercial, test and validation batches as per production schedule.
- Documentation of batches as per SOPs and written procedures.
- Preparation & revision of equipment and process related SOPs as per current operations.
- Responsible for general area cleanliness, sanitation and compliance to bio safety policies.
- Qualification of new equipment’s, preparation and execution of Qualification documents (URS, DQ, IQ, OQ and PQ).
- Responsible for execution of equipment’s PV and ensuring proper preventive maintenance of equipment’s.
- Data compilation and trend updation.
Relevant professional / Educational background
Any other requirements (If any)
Compensation / Reward
Biotech, Ahmedabad, GJ, IN, 382213