Dr. Sudesh Bhure
Ph.D Chemistry from ICT, University of Mumbai
Highly Experienced Pharmaceutical Professional having more than 27 years of progressive experience in leadership role in leading Indian MNC Cipla (1992-2015) & Glenmark (2016-2019) in the areas of quality operations , Analytical QC & R&D from product development to commercial launch.
Strong abilities in solving complex technical problems with proficiency in Quality systems implementation, Internal and external audits, technology transfer, method validations and Corporate QA activities.
Possesses strong knowledge of GxP systems and 21 CFR part 11, EMEA , ICH and USFDA guidelines .
Managed FDA and EU inspections, evaluated and responded to 483 observations.
Key member and subject matter expert in Harmonization and implementation of key quality management systems (OOS,OOT,CAPA).
Strong first hand experience in CSV and GAMP 5 implementation
25 plus international 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.