Have good knowledge in Granulation area Handling ACGTop spray granulation Machine, Compression area exposure for Handling Cadmach 45 station AWC Machine, Coating area exposure for Handling ACG coating Machine, Capsule filling exposure for Handling AF 25 machine.
Candidate who should have good knowledge in secondary packing area, track and trace, QMS activity. Require good knowledge in Complex Skid, NDDS, Lyo, Batch Manufacturing, Aseptic PFS, Vials Liquid, Autoclave, TS.
B.Pharm / M.Pharm; To perform equipment qualification, utility qualification activity with proper documentations. To perform Computer system validation. To investigate deviation, change request, OOS, market complaint etc.
Management and performing periodic observation of retain sample & identified the deviation through periodic observation. Review of Temperature, RH data in retained samples area.
Ensure preparation, review and submission of CTD sections in compliance with requirements of EMA, USFDA and other global markets. Timely update and preparation of dossier and documents as well as responses to the queries raised by regulatory agencies
Having exposure related Environment Monitoring in formulation, water analysis, various Microbiological test like sterility, BET, MLT etc. Having exposure related to regulatory plant and basic know of GLP GMP .Ready to work in rotational shift.
Intas is one of the leading multinational pharmaceutical formulation development, manufacturing and marketing companies in the world. Today, Intas is present in more than 85 countries worldwide and is growing at 20% CAGR. Around 70% of its revenues come from the international markets, particularly the highly regulated markets of EU and US. At Intas, every day and everyone works to create a world of good health, happiness and hope.
Having exposure related Environment Monitoring in formulation, water analysis, various Microbiological test like sterility, BET, MLT etc. Having exposure related to regulatory plant and basic know of GLP GMP. Ready to work in rotational shift.
Candidate should have experience in IPQA activities for Manufacturing. Packing area and Warehouse for Sterile Facility. Candidate should have experience in Sterile facility and good competency require in Qualification & Validation activities