Executive - DSP

Role & responsibilities

1. Ensure Facility monitoring, readiness, maintenance, equipment operations like Mixing vessels, TFF systems, AKTA systems, buffer preparation, chromatography techniques, autoclave operations, and coming in shifts basis for involving & supporting in continuous manufacturing of biological products at Bulk Manufacturing (BM) /production facility.

2. Preparation, review of process documents MFR, BPR, SOPs, protocols, related documents for downstream activity and responsible for timely closure and submissions.

3. QMS handlings i.e. initiation and closure of change control, deviation, CAPA related to Bulk Manufacturing.

4. Tracking of inventory of process raw materials & consumables used in manufacturing.

5. To understand and follow the safety practices and usage of PPEs in Bulk Manufacturing facility and during process.

6. Execution of Scale up of Development batches in Bulk Manufacturing facility with coordination of R&D support.

7. Coordination with engineering department and external vendor on tracking and completion of preventive maintenance/calibrations activities of Downstream process Equipment and instruments.

8. Follow good documentation practices (GDP) such as online documentation and ensuring cGMP compliance in downstream process and facility operations.

9. Following up with Vendors on equipment and instrument qualifications, trouble shoot/challenges etc., related to downstream process.

10. Coordination with stake holders and Involve in technical trainings, safety trainings related activities for smooth functioning in production facility.

Preferred candidate profile

Expertize in handling aseptic operation and other critical equipments in downstream production process.

Ensure compliance with quality management systems.

Must have knowledge on GDP, GMP practices during batch operation in commercial campaign.

Must have work experience in GMP environment.

Perks and benefits

As per Industry Norms