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. Job Type: Full-time 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
Role & responsibilities Maintains and documents proper records / log book / BPCRs / Reports as per GDP Handling of Chromatography, sterilization & Filtration techniques. Coordination with other department VIZ. engineering, QA, QC and R&D for smoothly execution of Technical Documents. Coordination with QA for timely issuance, completion, filling of BPCR and other GMP documents. Preparation of Performance Verification and PQ and commissioning protocol Understanding & execution of work in line with cGMP. Preparation of SOP, BPCR and other Technical Documents. Handling of QMS Documents, Handling of DMS. Execution of Training related activities of DSP area. To ensure the timely dispensing of raw material and Handling of SAP. To support in qualification activities of DSP area. Execution of Process validation batches. Filling of all records, Change Controls and QMS related Documents associated with DSP area. Execution of IQ, OQ, PQ of equipments of downstream area. Ensuring complete in-process quality control and continuous improvement in process capabilities. Investigating the OOS.OOT and handling process validation& cleaning validation. Plan and actively oversee team and shift activities to meet the production requirements Job Type: Full-time 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
Interact with the internal staff on a day to day basis for procurement analysis. Analyze the Product and accessories and Review quality of purchased products Coordinate with warehouse staff to ensure proper storage Monitor stock levels and place orders as needed Maintain updated records of purchased products, delivery information and invoices Prepare reports on purchases, including cost analyses Track orders and ensure timely delivery Review deliveries against the orders Enter order details (e.g. vendors, quantities, prices) into internal databases Research potential vendors Understanding of supply chain procedures Solid analytical skills, with the ability to create financial reports and conduct cost analyses Good knowledge of vendor sourcing practices (researching, evaluating and liaising with vendors) Compare and evaluate offers from suppliers Negotiate contract terms of agreement and pricing Proven work experience as a Purchasing Officer, Purchasing Agent or similar role Attend trade shows and exhibitions to stay up-to-date with industry trends Do Vendor registration in and out. Job Type: Full-time Pay: ₹20,000.00 - ₹30,000.00 per month Benefits: Cell phone reimbursement Food provided Internet reimbursement Leave encashment Paid sick time Paid time off Provident Fund Work Location: In person
Interact with the internal staff on a day to day basis for procurement analysis. Analyze the Product and accessories and Review quality of purchased products Coordinate with warehouse staff to ensure proper storage Monitor stock levels and place orders as needed Maintain updated records of purchased products, delivery information and invoices Prepare reports on purchases, including cost analyses Track orders and ensure timely delivery Review deliveries against the orders Enter order details (e.g. vendors, quantities, prices) into internal databases Research potential vendors Understanding of supply chain procedures Solid analytical skills, with the ability to create financial reports and conduct cost analyses Good knowledge of vendor sourcing practices (researching, evaluating and liaising with vendors) Compare and evaluate offers from suppliers Negotiate contract terms of agreement and pricing Proven work experience as a Purchasing Officer, Purchasing Agent or similar role Attend trade shows and exhibitions to stay up-to-date with industry trends Do Vendor registration in and out. Job Type: Full-time Pay: ₹20,000.00 - ₹30,000.00 per month Benefits: Cell phone reimbursement Food provided Internet reimbursement Leave encashment Paid sick time Paid time off Provident Fund Work Location: In person