Why This Role Stands Out
This hybrid CSV Lead role at HPTech Inc. offers a fantastic opportunity to leverage your LIMS and validation expertise within a reputable pharmaceutical and biotech environment. You'll thrive here if you possess strong GxP knowledge and enjoy leading validation efforts across projects, contributing to impactful system development. Apply today to join a dynamic team and advance your career in a flexible setting.
Quick Overview
Job Description
Job Title: CSV Lead
Location - Raritan, NJ (Hybrid)
W2/C2C
Mandatory Skills - LIMS – Lab Vantage & CSV
Job Summary:
• Experience in the Pharmaceutical, biotechnology with LIMS Labvantage related System Development Lifecyle in Computer System Validation Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation.
• Knowledge of FDA guidance’s and industry standards (i.e., GAMP)
• 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, systems and UAT test scripts and Test procedures.
• Ability to Review Automated Test script 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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