3-4

EM, Media 111 visual inspection , Aseptic area monitoring, Water and Bioburden testing & Sterility testing & BET Testiug , IQ, OQ, PQ of equipment, Biological reactivity test - Moda exposure

Should have sound knowledge of BFS machine operation, aseptic area, maintenance, media fill, batch mfg., CIP, SIP, Autoclave, topical manufacturing. Candidate having experience in different packing lines of OSD & sterile manufacturing.

Fermentation Microbial, mammalian, Proficiency in aseptic technique, exposure to Centrifugation, TFF, Homogenization operation, Filter integrity testing, CGMP, Autoclave operation, media preparation

Support affiliates in updating local requirements based on regulatory agencies guidance and input from affiliates, distributors. Manage working relationships with key stakeholders. Ensure compliance with regulatory requirements and provide strategic product direction to teams.

Should be able to develop analytical methods and perform analysis on UV, Dissolution, HPLC and ICP-OES instruments. Dissolution development, Comparative dissolution profile and multimedia dissolution study.

B.Pharm/M.Pharm/B.Sc/M.Sc; Production and Packaging, Planning, Monitoring and Reporting production activities. Purchase and procurement planning, monitoring and reporting purchase activities

Person should be well experienced in Environment Monitoring of Injcetable facility Settle plate, air sampling, surface monitoring and personnel gown monitoring. He must be aware of good documentation practices and aseptic behavior.

Collecting and submitting in-process samples, finished product samples, stability samples, control samples, cleaning samples, and other samples as per the respective procedures, batch manufacturing records and packing records, protocols. Conducting AQl inspections and periodic inspections of control samples

M.Pharm, B.Pharm, M.Sc, Handle QC instruments like HPLC, LCMS, GC,UV- spectrophotometer, dissolution apparatus, KF, IPC-OES, IR spectrophotometer. Handle QMS activities and maintain lab records.

B.Pharm / M. Sc; Handling the Lab instruments of HPLC, Dissolution, D. T., Apparatus, Weighting Balance, Friability, Hardness Tester, FTIR, UV-Spectrophotometer. Analysis of Raw Material, In-process, Finish Products, Stability Tastings, Process Validation, Participate in Lab incident/OOS/OOT/Analytical Deviation.