Online filling of the BPRs and records and performing jobs related to SAP, Operate equipment's reactor, Sparkler Filter, Candle Filters , Centrifuge, Dryers as per SOP
Dossier and document preparation as per CTD,ACTD and country specific guidelines, Review of dossiers, DMF and Technical documents, Answer query raised from regulatory authority, package insert, SmPC, PIL & MSDS preparation
M.Sc., B.E, B.Tech, M.Tech (Biotech, Chemical, Bioprocess, Microbiology
With 3-10 years of experience Hands on experience in Upstream, Downstream, Mammalian, Fill Finish, Single Use and Microbial Production etc.