Seetharam Kandarpa is a seasoned professional, Quality Expert, Auditor, Trainer, Data Scientist, ASQ ConnEx Expert and Consultant providing consulting services to Pharmaceutical/ Medical Devices/ Other GxP industries. He is Founder & Director of SHAARKVIEW CONSULTANCY.
A senior member of ASQ and currently holds various volunteer positions for member communities of ASQ such as:
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Vice Chair (VC) Member eNgagement - ASQ Quality Management Division
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VoC Chair- ASQ Customer-Supplier Division
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Leader of Community of Excellence, Drugs- ASQ Food, Drug, and Cosmetic Division
Seetharam 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. He holds various professional certifications such as:
- CMQ/OE, CPGP, CQA, CMDA, CSQE, CSSGB from ASQ
- Regulatory Affairs Certified (RAC-Drugs and RAC- Devices) from Regulatory Affairs Professional Society (RAPS)
- Certified Project Management Professional (PMP) by Project Management Institute (PMI)
- Certified ISO 13485 Internal Auditor by DQS (Deutsch Quality Systems).
Seetharam has over 22 years of industrial 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, Alembic and Aurobindo. He 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. He 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.
Seetharam has a rich experience in conducting training programs & presenting in professional seminars/ conferences across the world. He has proven expertise in dealing with large geographically and culturally diverse teams. Seetharam is an ASQ ConnEx expert to conduct training on the below ASQ ConnEx authorized courses:
Seetharam's Purpose of Career: "Learning Unknown, Helping Community & Earning Respect".