Why This Role Stands Out
This remote Validation Lead role offers significant opportunities to deepen your expertise in GxP validation and regulatory compliance, contributing to critical projects within a reputable company. You'll thrive here if you possess a strong background in CSV, enjoy collaborative problem-solving, and are adept at guiding validation efforts. Embrace the chance to develop your leadership skills and make a tangible impact from the convenience of your home office.
Quick Overview
Job Description
Role: Validation Lead
Location: Raritan, NJ(Hybrid)
Duration: 6+ Months
Job Description:
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
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