Review of the development documents and CMC documents as per regulatory standards. Gathering, managing and collating information from respective stake holders.
Biological E. Limited invites both experienced professionals and self-driven individuals to become part of its Speciality Injectables Business in Shamirpet, Hyderabad
Sr Quality Engineer will be an integral part of the design and development of combination products, providing quality oversight of the processes and deliverables generated throughout development and commercialization.
Ph.D./MD/MS/MDS or equivalent degree, or having 3 years of research, teaching, and design and development experience after MVSc/M.Pharm/ME/M.Tech with at least one research paper in Science Citation Index journal.
B.Pharm with State Pharmacy Registration Council. A letter of consent to the above condition should be given to join the post
Appointment of vacant posts is subject to change
Experience in granulation, compression, capsule & coating areas of a regulated market. FDA approval in tablet manufacturing would be preferred. Should have machine exposure of FETTE, Sejong, Cadmach for compression and FBD, FBE & RMG for granulation.
Experience in production planning, change control, line clearance, deviation handling, autoclave operation TS and component, aseptic & control area operation, documentation, both SVP and LVP manufacturing etc.
Granules India is a vertically integrated, high-growth pharmaceutical company with 38 years of proven performance and increasing performance and increasing presence across the world.