Minimum 5 years of experience in Computer System Validation (CSV).
Support for validation of GxP GEN AI based solutions is highly desirable.
Experience with mergers, acquisitions, or divestitures is a plus.
Background in the pharmaceutical, biotechnology, or medical device sectors.
Familiarity with FDA regulations and GxP standards, especially in risk-based validation.
Proficient in documentation for validation deliverables including test protocols and compliance reports.
Ability to review system test scripts, user acceptance tests, and design specifications.
Responsibilities
Lead validation reviews and execution of validation deliverables.
Develop and approve test plans and validation documentation.
Conduct thorough reviews of system test and user acceptance tests.
Coordinate validation activities across various projects.
Provide validation guidance and timely reviews to management.
Collaborate effectively with remote teams for project execution.
Ensure compliance with regulatory requirements throughout validation processes.
Benefits
Opportunities for professional development and growth.
Collaborative work environment with remote flexibility.
Engagement in innovative projects within a rapidly evolving industry.
Exposure to diverse teams and global operations.
Full Job Description
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.
bility to work as a team player, lead a team or accomplish tasks without supervision.
bility to work with remote teams and support several changes/projects simultaneously.
bility to provide Validation guidance, timely reviews, and escalations to TQ management.
