Contract role: Pharma Validation Lead at Raritan, NJ (Onsite - Hybrid Model)
Yochana IT
Validation Lead
Raritan, NJ (Onsite Hybrid Model)
Long Term Contract
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
Vacancy posted 3 days ago
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