Sr Executive - Manufacturing Upstream Process

Job Description

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