Himanshu S.

I have over 8 years of experience in Computerized System Validation and software testing, in the Medical Devices, Healthcare, and Life Sciences domains. I have executed projects based on GAMP 5 in adherence with 21 CFR Part 11, with expertise in the Validation process, Regulatory Risk assessment, business and functional requirement analysis, comprehensive test scenario creation, and test execution. Having authored processes and templates for creating a QMS, which is now ISO 13485: 2016 certified, I enjoy accelerating implementations to reduce the time to market for my clients. Key Skills:  Computer system validation (prospective) for GAMP category 4 and 5 systems, for one of top 3 pharmaceutical companies and Retrospective Validation of an array of GAMP category 1, 3, 4, and 5 products, effective 340 remediation.  High-quality Validation Plans/ Reports, IQ, OQ, and PQ test scenarios and scripts, creation, and execution.  Proficient in the end to end validation process execution, including ERES and Risk Assessments with Standard Operating Procedures and Requirement authoring (User, Functional specifications, and Detail design documents)  ISO 13485:2016, 21 CFR Part 11 and 820, Sarbanes-Oxley (SOX), EU Annex 11, GAMP 5, and ITIL.  Generate and execute verification and validation (System Testing, IQ, OQ, PQ, UAT) documentation for GXP and non-GXP computerized systems such as IT infrastructure, R&D (Pre-Clinical/Clinical, Medical Affairs, Regulatory Affairs, Pharmacovigilance), Commercial (CRM), Quality (Labs, Labeling/Artwork, QMS, Change Management, Deviations & Investigations, Training), Finance, HR, Legal/Corporate Compliance) Key Achievements: • Successfully validated the integration of CTMS software i.e. IMPACT with MDM and deployed in PROD within desired timelines • Remediation project planning and implementation for closure of audit findings with comprehensive CAPA and efficient Change management. • Test scenario creation, involving positive and challenge testing, based on functional risk assessment. Data Migration plan author and Test planning lead for Integration. • QMS author at the organization level