Having Injectable Experience of Shop floor supervising activities like filtration, Filling, Sealing, Stoppering, Garment Washing, Vial Washing, Autoclave, Ophthalmic, Suspensions, Lyophilizes. Operations and Training and QMS.
Validation professional with expertise in qualification / validation / re-qualification of instruments, equipment & utilities; hands-on validation through electronic systems; calibration & preventive maintenance.
The First Line Leader is accountable for developing and enabling a frontline team of operators to consistently deliver exceptional safety, quality, service and cost‑effective products.
India’s drug regulator has issued a public advisory after a consignment of insulin pens manufactured by Sanofi India Limited was reported stolen during transportation, raising concerns about potential risks if the products enter the market through unauthorized channels.
Biotechnology company Moderna has announced a major settlement to resolve global patent litigation with Arbutus Biopharma Corporation and Genevant Sciences GmbH over technology used in its mRNA vaccines. The agreement settles all ongoing lawsuits worldwide related to the companies’ disputes.
The Ministry of Health, Labour and Welfare (MHLW) in Japan has granted orphan drug designation to rilzabrutinib, a novel, oral, reversible covalent Bruton’s tyrosine kinase (BTK) inhibitor, for IgG4-related disease (IgG4-RD).
The regulator has announced that companies will now receive the No Objection Certificate, NOC more quickly, helping to streamline regulatory procedures and reduce approval timelines.