Job Description
Purpose of Job
Upstream Micrbial section
Skill Required
Responsible for dispensing, media / buffer preparation and execution of microbial upstream processing in manufacturing area for commercial production, validations, engineering, clinical batches and related documentation.
Roles and Responsibilites
- Dispensing of Raw materials and consumables as per BPCR.
- Execution of media preparation activities as per BPCR.
- Execution and processing of microbial cell culture operations for all commercial, test and validation batches as per production schedule.
- Responsible for general area cleanliness, sanitation, cGMP compliance of facility as per cGMP and SOPs.
- 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
Life science post graduate (M.Sc.)
Competencies
Intas - Action Oriented
Intas - Customer Focus
Intas - Dealing with Ambiguity
Intas - Problem Solving
Intas - Time Management
Relevant professional / Educational background
Must have 7-10 years of experience
Any other requirements (If any)
Must have handled the team of 8-10 personnel
Must have leadership qualities