Production Upstream Officer

1 week ago


Manjusar Vadodara Gujarat, India Bills Biotech Pvt. Ltd. Full time

Preparation and review of process documents (PCS, MFR, BMR,TTD), SOPs, protocols, investigation reports related documents for upstream activity.
- Responsible for LMS activities as a department training coordinator (DTC) for upstream.
- QMS handlings i.e. initiation, follow-ups and closure of change control, deviation, CAPA related to Bulk Manufacturing.
- Have clear understanding of Manufacturing and microbial commercialization activities of a biologics product & related documentation.
- Having wide experience in Microbial fermentation handling process Techniques (Handling of Bioreactors, Cell separation by Continuous Centrifuges, homogenizers).
- Extensive experience in trouble shooting process related issues during manufacturing.
- To understand and follow the safety practices and usage of PPEs in Bulk Manufacturing facility and during process.
- Execution of Scale up of Development batches/ other assigned tasks in Bulk manufacturing facility as per the assigned in shift hours.
- Ensure Facility monitoring, readiness & maintenance of BM facility.
- Coordination with engineering department on tracking and completion of preventive maintenance of Upstream Process Equipment and instruments.
- Following good documentation practices such as online documentation like BMR, equipment log books, record sheets etc. in upstream process.
- Following up with Vendors on equipment and instrument related to upstream process.
- Support, follow and fulfill for any additional work activities /other job responsibilities/tasks assigning by reporting manager.

Pay: ₹129,036.15 - ₹758,468.42 per year

**Benefits**:

- Flexible schedule
- Food provided
- Internet reimbursement
- Leave encashment
- Paid sick time
- Provident Fund

**Experience**:

- total work: 1 year (preferred)

Work Location: In person


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