Officer To Manager Manufacturing Upstream Process

Job Description

Role & responsibilities Preparation and review of process documents (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 product & related documentation. Having wide experience in Microbial fermentation handling process Techniques (Handling of Bioreactors, Single Use Fermenters, homogenizers). Extensive experience in trouble shooting process related issues during manufacturing. Tracking of inventory of buffers and consumables used in manufacturing through SAP related activities for commercial batches. 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 facility. Coordination with the 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 logbooks, record sheets etc. in upstream process. Following up with vendors on equipment & instrument related to upstream process. Support, follow & fulfill any additional work activities/other job responsibilities / tasks assigned by reporting manager. Preferred candidate profile The candidate prior experience in Single Use Fermenter, Single Use Systems, Centrifugation, Cell Lysis, Depth Filtration, Tangential Flow Filtration, strong GXP knowledge, clean room activities, filing of BMRs, deviations, CAPAs, etc. will be preferred. Perks and benefits As per Industry Norms