Validation Lead

2 days ago

Noida Uttar Pradesh, India CIEL HR Full time

Roles and Responsibilities - 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 Prudentia 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 o Define test strategy build test scenarios as necessary based on criticality of requirements o Testing effort estimation and resource management o Manage test execution o Perform CAPA Corrective and Preventive Actions and RCA Root Cause Analysis for test incidents and deviations o Review and reporting 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 o Validation Plan o Change Request o Risk Assessment Report o Test Plan o Test Scripts IQ OQ PQ UAT o Test Incident Reports o Trace Matrix o 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 o URS FRS o Risk Assessment o Configuration specifications o Validation Plan o IQ OQ PQ Test scripts authoring review execution o Trace matrix Validation Summary report

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