biswajit jayasingh

Having 9 years of rich experience with a demonstrated history of working in the pharmaceutical,medical equipment and life science sector on the areas of computer system validation/IT Quality Assurance ,Plant digitalization, Industry 4.0 and Compliance services. • Strong knowledge of Computerized System Validation concepts such as GAMP 5 – A Risk based Approach to Compliant GxP Computerized systems, CSV methodologies and regulations relating to Pharma,Life Sciences & Medical device Industry. • Expertise in developing documented deliverables throughout the CSV process, Risk Analysis and Mitigation,Plant digitalization,industrial automation,Project handling and co-ordination etc. • Successfully handled regulatory Audits as a wing lead for multiple regulatory Authorities (USFDA,EMA,DCGI,WHO etc). • Strong understanding on USFDA 21 CFR Part 11, part 210, 211, part 820, EU GMP Annex 11,WHO Appendix-5, ICH, HIPAA , GDPR , NIST,ISO, and exposure to Data Integrity requirements and other applicable regulations. • Maintaining the overall compliance of the project and system for regulatory Audits, and handling regulatory Audits as an SME in CSV and IT compliance. • Validated complex OT applications, SAAS and PAAS based Infrastructure applications,Data Historians ,Firmware based systems and IT Applications. • Good understanding of Quality System Elements such as Deviation handling, CAPA Implementation , QRM and change controls with thorough knowledge on Incident Management and Change Management, Periodic Review, Vendor Management, Quality Management Review Procedures, Periodic validation etc. • Well versed with ICH guidelines, ISPE framework on Risk Management and SDLC.