Dr. Sanjeev Kumar Gupta

About

All about Medical Devices & IVDs. Antigens (Native - Recombinant), Antibodies (Polyclonal & Monoclonals) and Diagnostic Kits (Rapid, ELISA, Latex EiA). Enterpre TB Mol. Diagnostic, Dental Aligners, Dental Cements, ECG, Non Invasive Vital Parameter Devices, Hydroxyapatite, Growth Factor Devices

Experience

• Managing Director & Chief Consultant at Intrust - Consulting LLP
  Mar 2020 - Present · 6 yrs 4 mos

  Consultant for MD-QMS & Regulation. All classes of MD & IVD. Trainings. Internal Audits. Risk Management

• President Quality and Regulatory Affairs at Advy
  Dec 2017 - Feb 2020 · 2 yrs 3 mos

  WHO-PQ Lead, Quality Lead for Diagnostic Kits, Diagnostic Antigens, Diagnostic Antibodies Regulatory Lead.

• Director Quality at Abbott Rapid Diagnostics (Earlier Alere Medical Pvt Ltd)
  Mar 2016 - Dec 2017 · 1 yr 10 mos

  Quality Operations (India). Customer Quality, Complaints, Feedback, QMS ISO 13485:2016, Facility Qualification, Process Validation,

• General Manager-Quality Assurance & Regulatory Affairs at Arkray Healthcare Private Limited, Surat
  Mar 2015 - Mar 2016 · 1 yr 1 mo

  Corporate QA Corporate RA QC Design & Development of IVDs Customer Service QMS WHO PQ Lead Process Validation

• General Manager-QA/RA at Span Diagnostics Limited
  Oct 2012 - Feb 2015 · 2 yrs 5 mos

  -WHO-PQ Lead Role -Corporate Quality Guidance -Overall responsibility for Quality of Products and Systems -Commissioning, Equipment Qualification, Process Validation -Planning and Implementation of Schedule M GMP and WHO Prequalification Requirements -Liaison between regulatory authority and company -Awareness and Training for QMS implementation and sustained operations -Responsible for building a full flagged team for Quality Assurance and Quality Control functions. -Product validation -CAPA -Risk Management -QMS Training