No of position: 2

 Job Location: Pan India

 Experience Required: 6-9 Years of Experience (PV is a must)

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
  • 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: 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 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
    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:
    Risk Assessment
    Configuration specifications
    Validation Plan
    IQ/OQ/PQ Test scripts (authoring/review/execution),
    Trace matrix & Validation Summary report.

Skills and Competencies

  • Excellent troubleshooting and communication skills
  • Timely attend and respond to assigned tasks as per business need.
  • Possesses good analytical and reasoning skills.


  • Tech/ BCA/MCA or any related bachelor’s degree