CSV Validation Lead

Role CSV Validation Lead

Location -Raritan, NJ(Hybrid)

Job Details:

5+ years of Computer System Validation (CSV) experience in GxP-regulated environments, with hands-on experience in retro-validation activities and 21 CFR remediation projects with knowledge of CSA, GAMP 5, 21 CFR Part 11, Annex 11, and audit/inspection readiness.

Experience in the Pharmaceutical, biotechnology, or medical device industry.

Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation.

Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements, Compliance/validation Plans, test protocols, Test Summary reports and Compliance/Validation Reports.

Experience in reviewing system test and user acceptance test scripts, Traceability matrix and Design Specs.

Experience in QA Methodologies, designing, reviewing and approving Test Plans, System/UAT test scripts and Test procedures.

Strong verbal and written communication skills.

Ability to work as a team player, lead a team or accomplish tasks without supervision.

Ability to work with remote teams and support several changes/projects simultaneously.

Ability to provide Validation guidance, timely reviews, and escalations to TQ management