Gopinath Sasitharan
Deputy General Manager -Quality & RA (MD/IVD Manufacturing) at Kriya Medical Technologies Pvt. Ltd.- Claim this Profile
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English Professional working proficiency
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Tamil Native or bilingual proficiency
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Bio
Dr. Selva
I know Gopinath for the last 5 years . He is a committed personality in his professional activities with orientation towards results . He is a good team player . He has the complete knowledge of the quality requirements of biologic for various markets . I wish him all the success in his future assignments .
RAJANGAM B
Gopinath is My Colleague when I am working in Lifecell International, He has Good Knowledge in Quality Control Works and he interested to learn New Techniques and he involve validation and internal audits also.
Dr. Selva
I know Gopinath for the last 5 years . He is a committed personality in his professional activities with orientation towards results . He is a good team player . He has the complete knowledge of the quality requirements of biologic for various markets . I wish him all the success in his future assignments .
RAJANGAM B
Gopinath is My Colleague when I am working in Lifecell International, He has Good Knowledge in Quality Control Works and he interested to learn New Techniques and he involve validation and internal audits also.
Dr. Selva
I know Gopinath for the last 5 years . He is a committed personality in his professional activities with orientation towards results . He is a good team player . He has the complete knowledge of the quality requirements of biologic for various markets . I wish him all the success in his future assignments .
RAJANGAM B
Gopinath is My Colleague when I am working in Lifecell International, He has Good Knowledge in Quality Control Works and he interested to learn New Techniques and he involve validation and internal audits also.
Dr. Selva
I know Gopinath for the last 5 years . He is a committed personality in his professional activities with orientation towards results . He is a good team player . He has the complete knowledge of the quality requirements of biologic for various markets . I wish him all the success in his future assignments .
RAJANGAM B
Gopinath is My Colleague when I am working in Lifecell International, He has Good Knowledge in Quality Control Works and he interested to learn New Techniques and he involve validation and internal audits also.
Credentials
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Certified Lean Six Sigma Green Belt
IMC InstituteMar, 2021- Sep, 2024 -
Risk Management: Master FMEA/FMECA & Criticality from A to Z
UdemyAug, 2020- Sep, 2024 -
Mini-Course MDR 2017/745
Easy Medical DeviceJun, 2019- Sep, 2024 -
ISO 13485:2016 Internal Auditor
SGSOct, 2018- Sep, 2024 -
ISO 9001:2008 internal auditor training
TUV Rheinland IndiaJan, 2013- Sep, 2024 -
Advanced Process Validation and Cleaning Validation
Malaysian Organisation of Pharmaceutical IndustriesSep, 2012- Sep, 2024 -
ISO 9001 internal auditor training
DNV SoftwareJan, 2008- Sep, 2024 -
GOOD CLINICAL PRACTICE
CDSA, THSTI, Faridabad with the sponsorship of BIRAC National Biopharma Mission in association with Biotech Consortium India Limited. -
Lean Six Sigma White Belt Certification
Six Sigma Society
Experience
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Kriya Medical Technologies Pvt. Ltd.
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India
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Medical Equipment Manufacturing
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1 - 100 Employee
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Deputy General Manager -Quality & RA (MD/IVD Manufacturing)
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May 2022 - Present
Medical Device & IVD Manufacturing Medical Device & IVD Manufacturing
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Self-employed
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Real Estate
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1 - 100 Employee
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Consultant- Medical device and Regenerative Medicine
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Nov 2021 - May 2022
Consultant for Sisco latex Pvt Ltd- Medical device for ISO 13485 Certification, CE Recertification & IMDR-2017 Class B Product registration. & Stempeutics Research Pvt Ltd for CQA (Regenerative medicine). Consultant for Sisco latex Pvt Ltd- Medical device for ISO 13485 Certification, CE Recertification & IMDR-2017 Class B Product registration. & Stempeutics Research Pvt Ltd for CQA (Regenerative medicine).
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Stempeutics Research Private Limited
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India
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Biotechnology Research
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1 - 100 Employee
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Manager Quality Assurance- Clinical & Corporate ( Regenerative Medicine & Topical, MD )
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Dec 2019 - Nov 2021
Regenerative Medicine & Topical, MD Regenerative Medicine & Topical, MD
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DGM - Quality and Regulatory Medical Device/IVD Manufacturing
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Mar 2018 - Dec 2019
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LifeCell International Pvt.Ltd
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India
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Biotechnology
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700 & Above Employee
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Dy.General Manager
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Jun 2017 - Mar 2018
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Dy. Manager Quality Assurance (Regenerative Medicine & Topical, MD)
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Apr 2014 - Jun 2017
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Asst.Manager QA/QC ( Regenerative Medicine & Topical, MD )
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Apr 2011 - Mar 2014
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Asst.Manager Q.C
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Jul 2010 - Apr 2011
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LifeCell international Pvt.Ltd
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India
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Biotechnology
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700 & Above Employee
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Quality control
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Jun 2007 - Jun 2010
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Education
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2015 - 2019
Sikkim Manipal University
Master of Business Administration (M.B.A.), Total Quality Management (TQM) -
2010 - 2011
Bioinformatics institute of india
Diploma, Pharma Regulatory Affairs -
2005 - 2007
University of Madras
M.Sc, Microbiology -
2002 - 2005
University of Madras
B.Sc, microbiology
Community
