Dr. Sudesh Bhure
Ph.D Chemistry from Institute of Science, University of Mumbai.
Highly Experienced Pharmaceutical Professional having more than 27 years of progressive and strategic experience in leadership role in leading Indian MNC,
Cipla Ltd. (1992-2015)
Glenmark Pharma (2016-2019)
Experience of QA and QC of API as well as wide range of Pharmaceutical dosage forms including Oral solid dose, Topicals, Liquid orals, Aspectically manufactured products, Inhalation products, Trans dermal patches, Creams and ointments.
Experienced of participating in regulatory inspections by USFDA, MHRA, ANVISA, TGA.
Experienced in responding to regulatory audit observations and tracking action to completion.
Development and management of GxP Quality Systems Experienced in Investigation’s, report writing, CAPA and effectiveness of CAPA (OOS, OOT, Batch failures) experienced in CSV and GAMP5, Internal and External audits, Market Complaints Experienced in Automation and organising work so as to increase output (Automated calculations, automated log book).
25 plus international paper publications.
Prashhant Kavalle
B.E. Electrical, MBA Finance Mumbai University,
MBA in International Business SDA Bocconi Milano Italy
Versatile, accomplished leader having 27 plus years of industrial experience in leading pharmaceutical project, engineering and operations . Proven track record with vast experience in setting up large scale greenfield pharmaceutical manufacturing facilities across the continents, strategic planning, capacity planning, engineering excellence, implementing engineering processes, engineering standards, best engineering practices & GMP across global manufacturing facilities.
Experience in solid orals, injectables, liquids, semi solids, respiratory, vaccine, API’s and biologics.
Subject matter expert in containment technologies, CSV & GAMP5 implmentation, clean room validation and 21 CFR part 11 compliance.
Extensive experience in managing projects from concept to Qualification and strong knowledge base in clean rooms and HVAC systems.
Suneeta Sule
MSC Analytical Chemistry Mumbai University
IRCA Certified ISO Lead Auditor
A professional with career span of 28 plus years in the respiratory field inclusive of six years of consulting Pharma companies, medical device manufacturers and capsule manufacturers
Over two decade of experience with two of India’s leading pharmaceutical companies in research and development for metered dose inhaler, Dry powder Inhaler and inhalation devices.
Experience of working with renown device design houses, medical device manufacturers, pharmaceutical companies, expedient manufacturer, capsule manufacturers and universities across Asia, UK and Europe.
Proven leadership role with problem solving, project de risking and sound technical abilities, experience of Risk assessment (FMEA), Root cause analysis and GAP analysis.
Experience of project coordination, design input, Evaluation, CE certificate of medical devices.
Experience of technical lead for setting up MDI facility.
Professional Journey:
During her professional journey spanning more than 25 years was associated with wide range of companies and professionals. Medical device design house viz Radius, cambridge design partnership, kinneir dufort, UPS cambridge, coalesce, jay precision.
Medical device manufacturers like prespart ltd., Apta, Nypro and Rexam, Pharmaceutical firms like Cipla, Watson, Lupin, Biocon and Sprirolife Care capsule manufacturers e.g. capsugel, suheung and ACG worldwide.
Equipment / Instrument manufacturers like harro hoffliger, PAM and Copley scientific.
Universities like University of Bath, BCP and SNDT university of Mumbai.
Dr. Suhas R. Mangaonkar Ph D.
Sterility Assurance; Aseptic practices & Process;
Pharmaceutical / Nutraceutical / Food / Cosmetics Microbiology and Biotechnology
Pharmaceutical / Nutraceutical / Food / Cosmetics Microbiology and Biotechnology
About 25 years of experience in Pharmaceutical industry in R & D and Sterility assurance
function, in lead role, in various professional organizations.
Skills & Expertise:
- Pharmaceutical Microbiology, Sterility Assurance.
- Cell Biology. Cell assay development.
- Therapeutic Monoclonal Antibodies
- GMP / GLP / Validation
- Regulatory Audits
Education:
Ph. D. Microbiology: From Bhabha Atomic Research Centre (BARC), 1995.
M.Sc. Biochemistry: From Grant Medical College, University of Mumbai. 1989
M.Sc. Biochemistry: From Grant Medical College, University of Mumbai. 1989
Work:
External faculty at ICT (UDCT), Matunga, Mumbai for Microbiology -2019
Mylan Labs Ltd., Head Aseptic process and practices, Sterility Assurance, Corporate Quality Assurance Injections – Year 2015 to 2019
Cipla Limited: Head Microbiology & amp; Cell Biology Corporate Quality Assurance – Year 2002 to 2015
Sandoz Private Limited: Head Microbiology, Quality Assurance – Year 1999 to 2002
Hoechst Marion Rousell: Research Scientist. Project drug discovery – Year 1995 to 1999
External faculty at ICT (UDCT), Matunga, Mumbai for Microbiology -2019
Mylan Labs Ltd., Head Aseptic process and practices, Sterility Assurance, Corporate Quality Assurance Injections – Year 2015 to 2019
Cipla Limited: Head Microbiology & amp; Cell Biology Corporate Quality Assurance – Year 2002 to 2015
Sandoz Private Limited: Head Microbiology, Quality Assurance – Year 1999 to 2002
Hoechst Marion Rousell: Research Scientist. Project drug discovery – Year 1995 to 1999