Validation Lead

Ciel HR

Noida, Uttar Pradesh
Permanent
Full-time

25 days ago

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 managemento Manage test execution,o Perform CAPA (Corrective and Preventive Actions) and RCA (Root Cause Analysis) for test incidents and deviationso 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 Requesto Risk Assessment Reporto Test Plano Test Scripts: IQ, OQ, PQ/UATo Test Incident Reportso Trace Matrixo Test/ValidationSummary 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.

Ciel HR

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