Sr Executive - Manufacturing Upstream Process

Role & responsibilities

• 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.
• Tracking of inventory of buffers and consumables used in manufacturing through MDO/ Prosol tools/SAP related activities for commercial batches.
• Sound knowledge on Track wise, EDMS, EBMR request.
• 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.

Preferred candidate profile

Candidates working in the field of Biotechnology will be Preferred

Perks and benefits

As per Industry Norms