Validation Lead
Ciel HR
- Noida, Uttar Pradesh
- Permanent
- Full-time
- 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:
- 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
- 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