SACHIN GORADE, Deputy General Manager, Sterile Fill Finish, Lupin

An accomplished Pharma and Biopharma professional with hands on experience in injectable formulation / manufacturing equipment/utility/system validation, aseptic process validation, aseptic manufacturing and vaccine formulation.

•   Around 20 years’ experience in Pharmaceutical technical operations including manufacturing, qualification, validation, quality, microbiology, greenfield and brownfield projects.
•   Handled audits from the regulatory agencies, such as USFDA, MHRA, EMA, HPRA, TGA, MCC, Health Canada, WHO, ANVISA, Federal institute for drugs and medical devices (BfArM)Germany etc.
•   Investigation, troubleshooting and resolution of complex technical problems originating during manufacturing / qualification / validation.
•   Continuous improvement of manufacturing / qualification / validation procedures.
•   Development of a high performing and sustainable team.
•   Experience in response to technical queries on submission of documents for product filing, GMP deficiencies, Inspectional observations including FDA 483’s and warning letter.
•   Structuring Capex / Opexbudget and judicious deployment of resources to achieve maximum operational efficiency.