Job Description

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.