Bikash Sarkar

Directed enterprise QMS strategy and eQMS governance, aligning to ISO 13485 and advising C-suite as Deputy Management Representative. Led risk-based quality and inspection readiness programs (FDA/ISO/MDR), achieving zero critical observations and cutting major audit findings by 40% through streamlined CAPA, deviations, and change control, plus compliance analytics for executive decision support.

Executed end-to-end Computer System Validation using risk-based validation, GAMP 5 methodology, and 21 CFR Part 11 compliance to strengthen GxP system integrity. Standardized validation lifecycle documentation (URS, FS, DS, IQ/OQ/PQ) and data integrity controls using ALCOA+ principles to close compliance gaps and improve inspection readiness.

Led enterprise-scale validation programs across GxP-regulated environments, driving end-to-end CSV delivery and aligning consulting teams to global regulatory expectations. Implemented risk-based governance and standardized delivery models to strengthen compliance posture and improve turnaround time across concurrent engagements.

• Led infrastructure qualification (IQ/OQ/PQ) activities ensuring full compliance with 21 CFR Part 11, GxP, and data integrity
requirements, resulting in audit-ready regulatory deliverables and zero critical observations.
• Reviewed and approved QP, IQ, OQ, and Qualification Reports for regulated systems, ensuring end-to-end validation lifecycle compliance and traceability.

• Operational Quality Manager: Reviewed and approved URS, FS, DD, IQ, OQ, PQ with Functional Risk Assessment ensuring FDA 21 CFR Part 11 and GxP compliance.
• Project Quality Manager: Executed SAP PS4 (ChaRM) ERP validation lifecycle; authored CSV Plan, Validation Plan, IQ/OQ, RTM documents.

Completed an MBA in Finance at IleBM in Pune.

Completed an M. Com in Accounting at Harish Chandra Degree College in Varanasi.

Completed a B. Com in Accounting at Harish Chandra Degree College in Varanasi.