CSV Specialist at Katalyst CRO in Raritan, NJ

Job description

• Job Description

Responsibilities

• Provide Validation guidance, timely reviews, and escalations to TQ management.
• Work with remote teams and support several changes/projects simultaneously.

Requirements

• Min 5 years of CSV experience.
• experience supporting validation of GxP GEN AI based solutions is a major plus
• experience supporting mergers/acquisitions/divestitures is a major plus
• 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.

Skills

Required

• CSV (Computer System Validation)
• GxP standards
• Risk based validation
• Traceability matrix
• Design Specs
• QA Methodologies
• System/UAT test scripts
• Test procedures

Preferred

• Validation of GxP GEN AI based solutions
• Mergers/acquisitions/divestitures