Sanjay Singh

About Sanjay Singh

Highly skilled Quality and Validation expert with demonstrated history of working in the Pharmaceutical and IT Consulting Industry. Skilled in Pharmaceuticals/IT Quality (ITQA), Computer System Validation/ Computer Software Assurance (Risk based Validation), Infrastructure Qualification, Quality Management System, Clinical Operation (GCP), Analytical Lab (GLP), Good Manufacturing Practices (GMP), Pharmacovigilance (GVP) and Regulatory Department. Core expertise:#Specializes in handling of Validation Deliverables (Risk Assessment, Supplier Assessment, Data Integrity, Validation Plan and Summary, Requirement and Design Specifications Document, Test plan and Script, RTM, and DI Summary report) And Quality Management System (Nonconformities/ Deviation, CAPA Management, Incident Management, Problem Management, Configuration and Change Control Management).#Handled and Validated ERP applications like Veeva Vault (Quality and Clinical Vault), AI/ML Model, TrackWise Digital, Document Management System (eDMS), LIMS, RPA- Bots, and Empower.#Expertise in Vendor Audit, Internal Audit (IT/IS and GxP Application), System Periodic Review, Data Integrity, and Training management.#Hand on experience in- Quality System, and Computer System Validation /CSA (Agile and V-model).#Excellent knowledge on GxP guidelines like GAMP5, Annex 11 and 22, 21 CFR part 11, 50, 54, 56, 820, 210, 211, ISO 9001, GCP, GLP, ICH (Efficacy, Quality, Safety and Multidisciplinary), Health Canada, EMA, TGA, NPRA, and its requirements and expectations.#Experience of working closely with the global stakeholders.

Experience

1. Senior Specialist, IT Validation Services

   百时美施贵宝

   Aug 2025 — Present · Hyderabad, IN

Education

• Dr. A.P.J. Abdul Kalam Technical University

  Bachelor of Pharmacy - B.Pharm, Pharmacy

  2011 — 2015

• NIPER Hyderabad

  M.S. Pharm, Medicinal and Pharmaceutical Chemistry

  2015 — 2017