Validation Consultant

4 weeks ago

Noida, Ghaziabad, India Neufvasi Digital Solutions Private Limited Full time

We're on the hunt for a validation virtuoso with experience of 7+ years to join our client at Noida

Job Description :

- If you're passionate about CSV and SDLC concepts like V-Model, Waterfall, and Agile Scrum, we want to hear from you.

- But wait, there's more We need someone who's not just familiar with regulations and guidelines in the life sciences/pharma industry (think GAMP, GxP, 21 CFR Part 11, EU Annex 11, GDPR), but who lives and breathes them.

- And if you happen to have a secret weapon - knowledge of Pharmacovigilance (PV) computer systems - well, that's music to our ears.

- But here's the kicker: we need someone who's not just talk. We need someone who's hands-on, who's tackled validation deliverables like URS, FRS, Test Scripts, and Validation Summary reports with finesse.

As a Validation Consultant you would :

- 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 company's 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 report 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.

(ref:hirist.tech)

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