Good exposure require in IPQA - OSD and Sterile, Qualification OSD and Sterile. Intas is one of the leading multinational pharmaceutical formulation development, manufacturing and marketing companies in the world.
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.