Validation Lead
AppLab Systems, Inc · Raritan, NJ · 2 wk ago
On-siteQuality AssuranceContract
Location: Raritan, NJ (Hybrid). Duration: 6 month(s)+ (Contract).
Requirements
- 5+ years of Computer System Validation (CSV) experience in GxP-regulated environments
- hands-on experience in retro-validation activities
- 21 CFR remediation projects
- 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 (e.g., 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