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
Candidate who should have good exposure in Tablet Packing Primary and Secondary packing Area Must have knowledge and exposure in CAM NMX and HV 1 Machine. Knowledge of SAP will be an added advantage.
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.
B.Pharmacy, M. Pharmacy, M. Sc.,B.Sc., Diploma with relevant functional experience in injectable manufacturing, Aseptic area operations, Packing, Visual inspection, QMS activities