Overview
Remote
On-site
Job Description
Roles & Responsibilities :
- 21 CFR Part 11/820, GxP, GAMP 5, SOX, EU Annex 11/22, ISO 9001, ITIL, EU Anness 22, ISO 9001, ITIL, Audit/inspection readiness, periodic reviews, access roster and audit trail reviews, Deviation/CAPA management, SOP/policy compliance processes
- Authoring of URS/FS, protocols, final reports, validation plan/report
- High-level understanding of Veeva Vault suits
- Risk-based testing aligned to CSA fundamentals
- High-level understanding of Biostatistics, Clinical, Discovery, Medical Affairs, Pharmacovigilance, Regulatory Affairs, RPA GxP BOTs, R&D AI GxP
Education & Experience :
- Bachelor of Science OR Bachelor of Technology OR Bachelor's in Pharmacy
- Experience: Over 8+ years of overall experience with at least 5 years of experience in Computer System validation for GxP system
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FAQs About Computer System Validation Engineer Jobs at Katalyst Healthcares & Life Sciences
What is the work location for this position at Katalyst Healthcares & Life Sciences?
This job at Katalyst Healthcares & Life Sciences is located in Wilmington, DE, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at Katalyst Healthcares & Life Sciences?
Employer has not shared pay details for this role.
What employment applies to this position at Katalyst Healthcares & Life Sciences?
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