4-5

M.Sc / B.Pharm / M.Pharm. Material Dispensing, Ointment, Gel Manufacturing, Filling, Packing, Track and Trace, Labelling, Cartonator, QMS. IPQA, Document Cell, OOS, OOT, Process/ Cleaning Validation, Review of BMR & BPR, Training ,QMS Investigation, CAPA, SOPs etc.

He, she participates in all activities relating to preparation, submission and follow up to obtain approvals, renewals for products and its variations and line extension indications and labeling approvals of medical devices of various business units of Medtronic. He, she will be responsible for providing technical support by interpreting federal and local regulations as they apply to products, processes, practices and procedures

Supervision of aseptic area activities, shift handling, aseptic area documentation, media fill activities, aseptic behaviour monitoring, and sterile operations. Handling area cleaning and sanitation activities, supervising steam sterilizer loads, filter integrity, disinfectant preparation and filtration activity, and related documents.

M.Pharm, B.Pharm, M.Sc, B.Sc. Functional experience in Calibration, Instrumentation, QMS activities. relevant functional experience in OSD manufacturing and Packing operations / QMS activities. Through knowledge on cGMP norms & Laboratory safety

BSC /MSC/ B.Pharm/ M.Pharm; Having experience in government tendering, CPP portal, Having exp. in MS Office & fluency in English.. Willingness to learn new things, Open for Challenges, Computer Skills, Ready to work in shift. Having experience Daily Maintenance work, knowledge of utility, Plant Maintenance, Electric and mechanical work. Having experience of handling of HPLC, GC & Documentation

M.Sc. / B. Pharm / M. Pharm. Review of Electronic data on various QC instrument Like HPLC, GC, FTIR, UV-Visible Spectrophotometer, TOC analyzer etc. Details experience on Audit Trail review of All QC instruments. Hands on Experience on Various QC instrument calibration like HPLC, GC, FTIR, Polarimeter, UV-Visible Spectrophotometer, Dissolution etc. Experience on Handling of OOS, OOT, OOC, Laboratory Incident investigation, Deviation etc.

Require experience in IPQA, IPQA Sterile, Qualification Sterile, Validation Sterile, Analytical QA, Stability Studies, regulatory affairs, OOS investigation Microbiological, Risk Assessment, Market Complaint, QA Documentation, Exposure in QMS, Deviation, CAPA etc with Trackwise system.

B. Pharm, M. Pharm, B.E, B.Tech. with relevant experience in handling operations of packing line machine i.e. Plunger insertion cum labeling, vial labeling, Blister, Catenator, Track & Trace. experience supervising and controlling production areas like Aseptic Filling, Vial Washing, Autoclave and Lyophilizer. Exposure of machine qualification activity will be added advantage.

M.Pharm / Ph.D in Pharmaceutics studied in Top Colleges; Test license application. Preparation of costing formula. Execution of Bio batches. Raw materials and Packing materials procurement. Pre-formulation studies. Master formula record and specification reviews. Formulation development and scale up. Stability Studies.