Ameya Kulkarni

Biography

  Experience Deputy Manager Company NameSerum Institute of India Limited Dates EmployedFeb 2013 – Present   Employment Duration4 yrs 8 mos LocationPune Manager Company NameRanbaxy Laboratories Ltd. Dates EmployedFeb 2011 – Jan 2013   Employment Duration2 yrs LocationBangalore Involved in setting up production facility for manufacturing of Hib and typhoid vaccines. Involved in area qualification. Involved in utility modifications and qualifications. Review of P & I diagrams for equipments. Review of material flow, personnel flow, process flow diagrams. Involved in facility modifications. Inputs in procuring equipments for the processes. Preparation of URS for new equipments. Preparation and review of SOPs. Preparation and review of validation protocols. Review of technology transfer BMR. Co-ordinate with different departments such as QA, QC and R&D. Preparation for DCGI Audit. Preparation of validation documents. Preparation, review and revision of documents required for the process. Acting as overall in-charge for downstream processing of the Hib and Typhoid vaccines. Completed successful demonstration batches for Hib vaccine. Assigned as a training co-ordinator for production team. Responsibilities involve Preparation of training matrix and scheduling training for the team. FAT of different process equipments. IQ, OQ and PQ of different process equipments. Instrumental in: Technology transfer of Haemophilus Influenzae Type-b and typhoid Vaccines in coordination with R & D Department As Manager (Bio-process) Company NameShantha Biotechnics Limited,Part of Sanofi Aventis Group Dates EmployedAug 2007 – Jan 2011   Employment Duration3 yrs 6 mos LocationHyderabad Process validation in HIB Conjugate Vaccine Manufacturing. Process validation in whole cell pertussis Vaccine Manufacturing. Involved in preparation of supply chain management module. Active participation in development of MIS for operations. Execution of FAT, IQ, OQ & PQ of equipments like TFF systems, chromatography systems, vessels etc. Planning product campaigns to meet annual targets. Managing resources for smooth operation of campaign. Proposing plans for yield/process improvement. Co-ordinate with different departments such as QA, QC and R&D. Involved in the preparation for WHO Audit and coordinating with the QA and QC team. Preparation of validation documents. Participation in change control, failure investigation and deviation reporting processes. Participation in route cause analysis and CAPA. Performing risk assessment using FMEA. Preparation, review and revision of documents required for the process. (Includes protocols, BMRs, SOPs, RSTs etc.) Acting as overall in-charge of the Hib and pertussis manufacturing processes. Manufacturing data compilation, analysis and trending. Training production team. Involved in troubleshooting activities. Preparation of BOMs for SAP. Day to day activities viz. indenting, work request, product posting, product dispatch in SAP system. Production Executive: Company NameShantha Biotechnics Limited,Part of Sanofi Aventis Group Dates EmployedAug 2006 – Jul 2007   Employment Duration1 yr LocationHyderabad Area, India Instrumental in: Technology transfer of Haemophilus Influenzae Type-b Vaccine (Approved by WHO) in coordination with R & D Department. Process scale-up studies, improvement, validation and standardization. Prepared various documents like lot records, SOPs, process procedures, etc and conducted IQ/OQ/PQ of various instruments. Training: Quality systems Validations and qualifications Sterile product manufacture Risk assessment techniques  CAPA Filtration techniques Commenced career as Supervisor Company NameSiddharth Colourchem Ltd Dates EmployedOct 2003 – Mar 2004   Employment Duration6 mos Supervising troubleshooting production operations on daily basis)

Research Interest

 Chromatography, technology transfer