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:
URS
FRS
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.
Education
- Tech/ BCA/MCA or any related bachelor’s degree