Computer System Validation Engineer Job at Katalyst Healthcares & Life Sciences, Wilmington, DE

  • Katalyst Healthcares & Life Sciences
  • Wilmington, DE

Job Description

Job-ID32849280Reference26-01443Remote50% Remote 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

Job Tags

Remote work

Similar Jobs

Emprise

Senior Marine Engineer Job at Emprise

 ...premier products and services that help our clients operate more effectively and efficiently. Were looking for talented Senior Marine Engineers who will be responsible for coordinating and overseeing the maintenance, repair, and safe operations of all the engineering... 

Wine Source Group USA

General Manager / Country Manager Job at Wine Source Group USA

 ...Attributes Entrepreneurial spirit and problem-solving mindset. Excellent communication skills. Ability to operate in an international environment. Location Based in New York, with regular travels across other states. KPIs / Success Indicators Revenue... 

Corevia Staffing

C# Developer Job at Corevia Staffing

 ...C# Developer Location: Charlotte, NC W2 Candidates with 12month validity Local as F2F required Must have Skills: 5+ years of experience in C# with experience building scalable, high-performance backend services 3+ years of experience with... 

La Clinica

Health and Wellness Coach Job at La Clinica

 ...Health and Wellness CoachFull-Time | Non-ExemptLa Clinica Center for Learning and InnovationBilingual in Spanish and English required.We're committed...  ...why our employees love working at La ClinicaThe Wellness Coach provides support to both patients and the care team in... 

HR Group LLC Companies

Journeyman Electrician for ELECTRA LLC Job at HR Group LLC Companies

 ...for installing, maintaining, troubleshooting, and repairing electrical systems in commercial, industrial, and/or residential environments...  ...systems in new construction and renovation projects. 2. Maintenance & Repair Inspect, troubleshoot, and repair electrical...