Validation Consultant - Virtuoso

We're on the hunt for a validation virtuoso with experience of 7 years to join our client at Noida Job Description : - If you're passionate about CSV and SDLC concepts like V-Model, Waterfall, and Agile Scrum, we want to hear from you. - But wait, there's more We need someone who's not just familiar with regulations and guidelines in the life sciences/pharma industry (think GAMP, GxP, 21 CFR Part 11, EU Annex 11, GDPR), but who lives and breathes them. - And if you happen to have a secret weapon - knowledge of Pharmacovigilance (PV) computer systems - well, that's music to our ears. - But here's the kicker: we need someone who's not just talk. We need someone who's hands-on, who's tackled validation deliverables like URS, FRS, Test Scripts, and Validation Summary reports with finesse. As a Validation Consultant you would : - Act as SME for Computer System Validation (CSV) for GXP based computerized systems developed internally and deployed for customer implementations. - Work closely with cross functional groups, including Design, Development and Business Analysts to deliver results. - Define risk-based validation strategy & execute in line with company's QMS (Quality Management System) - Participate in assessments including System impact assessment, functional risk assessment, data integrity assessments etc. Manage End-to-End System Testing Life Cycle (STLC), like : - Define test strategy, build test scenarios as necessary based on criticality of requirements, - Testing effort estimation and resource management Manage test execution, Perform CAPA (Corrective and Preventive Actions) and RCA (Root Cause Analysis) for test incidents and deviations - Review, and report Test Results in line with System Testing Life Cycle. - Participate in end-to-end change management including handling deviations both during the project and operation phase. - Author and peer review of key validation documents, as per Good Documentation Practices. Validation documents such as : - Validation Plan, Change Request Risk Assessment Report - Test Plan - Test Scripts: IQ, OQ, PQ/UAT - Test Incident Reports - Trace Matrix - Test/Validation Summary Required Experience and Knowledge : - Good knowledge of CSV and SDLC concepts: V-Model, Waterfall, Agile Scrum etc. - Exhibit good understanding of regulations/guidelines applicable to Life sciences/Pharma industry like GAMP, GxP, GDP, 21 CFR Part 11, EU Annex 11, GDPR etc. - Knowledge of Pharmacovigilance (PV) computer systems (Preferred) - Sound knowledge of validation of GxP systems (on cloud / on premise solutions) - Hands on with Validation deliverables like URS, FRS, - Risk Assessment, Configuration specifications, - Validation Plan, IQ/OQ/PQ Test scripts (authoring/review/execution), Trace matrix & Validation Summary report. (ref:hirist.tech)

Location: Noida, IN

Posted Date: 4/24/2024