Shaarkview Consultancy

Seetharam Kandarpa

MS Data Science; M.Sc. Chemistry; PMP, ASQConnEx Expert, ASQ CMQ/OE, ASQ CQA, ASQ CMDA, ASQ CSQE, ASQ CPGP, ASQ CSSGB, RAC Drugs, RAC Devices

23 years experience

A seasoned professional, ASQConnex Expert, Trainer, GxP Auditor, Data Scientist and GxP Consultant providing consulting services to Pharmaceutical/ Medical Devices/ Food Products/ Other industries. A Certified Manager of Quality/ Organizational Excellence (CMQ/OE), Certified Pharmaceutical GMP Professional (CPGP), Certified Quality Auditor (CQA), Certified Medical Device Auditor (CMDA), Certified Software Quality Engineer (CSQE) and Certified Six Sigma Green Belt (CSSGB) by American Society for Quality (ASQ), Regulatory Affairs Certified (RAC-Drugs and RAC- Devices) holder from Regulatory Affairs Professional Society (RAPS), Certified Project Management Professional (PMP) by Project Management Institute (PMI) and Certified ISO 13485 Internal Auditor by DQS (Deutsch Quality Systems). Has 22+ years of experience in the areas of Production & Quality Assurance in GxP Industry in various leadership positions with major companies such as Abbott, Ipca, Dr. Reddy's, Mylan (Viatris), Alembic and Aurobindo. A senior member of ASQ and currently holds various volunteer positions for member communities of ASQ such as: Vice Chair (VC) Member eNgagement - ASQ Quality Management Division VoC Chair- ASQ Customer-Supplier Division Leader of Community of Excellence, Drugs- ASQ Food, Drug, and Cosmetic Division ​ Has a versatile experience in complying various regulations/ standards such as 21 CFR, ICH, WHO, EMA, PIC/S, Canada GMP, TGA, GAMP5, ISO 9001, ISO14001, ISO 13485 and ISO 19011 etc. Has experience in conducting, as Lead Auditor, audits of GxP sites, dealing with quality system elements such as personnel training, quality risk management, deviation, change control, internal audits, supplier management, management review, complaints, recall, CAPA etc. and working with GxP software applications such as TrackWise, ISOtrain, SumTotal, myProcess, AR/ VR training programs. Has a rich experience in conducting training programs & presenting in professional seminars/ conferences across the world. Has proven expertise in dealing with large geographically and culturally diverse teams.​ ​ Did MS in Data Science from Eastern University, USA in 2024; M. Sc. in Chemistry from MP Bhoj (Open) University, India in 2006; and B. Sc. in Chemistry from Andhra University, India in 2002. LinkedIn Profile: https://www.linkedin.com/in/seetharamkandarpa/ Purpose of Career: Learning Unknown, Helping Community & Earning Respect