Employer description & source details
Execute validation activities for computerized systems and software in compliance with GxP, 21 CFR Part 11, and applicable regulatory requirements. Develop and maintain validation documentation, including validation plans, test scripts, traceability matrices, summary reports, and release documentation. Partner with IT, Quality Assurance, business stakeholders, and external vendors to define validation strategies and ensure successful project delivery. Coordinate and oversee validation testing activities, ensuring requirements are appropriately tested and documented. Manage defects, deviations, and incidents identified during testing, including triage, resolution tracking, and closure documentation. Facilitate review, approval, execution, and post-execution management of validation and qualification documentation. Train and support project teams on validation procedures, tools, documentation standards, and best practices. Provide ongoing guidance on change management for validated systems and stay current with evolving regulatory requirements and industry standards. Bachelor's degree in Computer Science, Information Technology, Engineering, Software Development, or a related field with 3-5 years of relevant experience, or equivalent combination of education and experience. Experience validating GCP-regulated computerized systems and software, ideally within the pharmaceutical, biotechnology, medical device, or other highly regulated industries. Strong understanding of quality system principles, including validation, documentation, change control, training, and audit readiness. Proven ability to collaborate effectively in cross-functional and matrixed environments, building strong relationships with internal stakeholders, business partners, and external vendors. Excellent
Extracted skills: gcp