@pankajbisht2
I build compliant GxP software validation strategies for pharmaceutical, biotech, and medical device platforms.
IndiaAt Roche Services India, I define and execute GxP compliance strategies for global computerized software platforms, embedding quality-by-design and data integrity controls across product lifecycles.
Previously at Cognizant and Arcolab, I led CSV deliverables and digital validation initiatives, reducing verification effort by 30%, validation cycle time by 35%, and compliance processing time by 40%.
Work history, roles, and key accomplishments
Oct 2025 - Present (11 months)
Defined and executed compliance strategies for global computerized software platforms, aligning product roadmaps with GxP regulations and cloud compliance. Partnered with software architects, product managers, and regulatory teams to embed quality-by-design and data integrity controls across the solution lifecycle.
Sep 2022 - Oct 2025 (3 years 1 month)
Authored validation deliverables (Validation Plans, URS/FRS, Test Scripts) for enterprise systems per GAMP 5, reducing verification efforts by 30% via risk-based approaches. Managed CSV project lifecycles using MS Project and deployed training initiatives onboarding 200+ cross-functional stakeholders across global business units.
Arcolab Private Limited
Mar 2021 - Sep 2022 (1 year 6 months)
Oversaw digital Validation Lifecycle Management Systems (VLMS / Valgenesis), ensuring continuous compliance, automated workflow tracking, and seamless system integration. Modernized the digital validation framework, streamlining compliance approval workflows and reducing validation cycle time by 5%.
Degrees, certifications, and relevant coursework
Bachelor of Technology, Electronics & Communication Engineering
2013 - 2017
Bachelor of Technology in Electronics & Communication Engineering from Uttarakhand Technical University, Dehradun, from 2013 to 2017.
Product & Systems Strategy Management, Product & Systems Strategy Management
Completed certification in Product & Systems Strategy Management.
Agile Software Testing & Quality Methodologies, Agile Software Testing & Quality Methodologies
Completed certification in Agile Software Testing & Quality Methodologies.
Software and tools used professionally
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