| CSV specialist | Remote | Contract at Remote, Remote, USA |
| Email: [email protected] |
| From: Shalman M, Securekloud Technologies [email protected] Reply to: [email protected] Hi , Greetings !!! This is Shalman from Securekloud, We do have opening for our client, Role : Computer System Validation Specialist Location : Remote (EST Timings) Duration : Long-Term Contract Job Description : Role and Responsibilities: Possess hands-on experience with the Veeva Vault Quality Docs System. Develop Computer System Validation (CSV) deliverables including Validation Plan, Validation Protocols (IQ, OQ, PQ), Validation Summary Report, Data Migration Plan and Trace Matrice. Conduct GxP Risk Assessments on computer applications utilized in regulated environments. Perform system assessments in compliance with 21 CFR Part 11 and Annex 11 regulations. Collaborate with Business Users, System Owners, IT teams, vendors, and Business Analysts to define validation requirements and plans. Provide oversight and training related to validation activities to multi-functional teams. Coordinate and support User Acceptance Testing (UAT) and Data Migration Activities. Review defects and collaborate with IT/Vendors for resolution, scheduling defect triage meetings as necessary. Act as the subject matter expert (SME) for CSV activities and maintain expertise in the CSV domain. Professional Work Experience: Bachelors or masters degree in engineering or a related field (equivalent education and work experience may be considered). 12+ years of experience in a Computer System Validation role within the pharmaceutical, biotech, or other regulated industries. Demonstrated experience in software quality assurance processes, Software Development Life Cycle (SDLC) methodologies, IT change management, documentation, verification, and validation techniques. Hands-on experience validating and maintaining the Veeva Vault Quality Docs system and data migration. Understanding of GAMP 5 techniques, software industry standards, and their implications on internal procedures and software quality. Working knowledge of FDA Quality System Regulation, 21 CFR Part 11 and Annex 11 regulations. With Regards, Shalman M Associate - US Staffing SecureKloud Technologies Limited Direct : 510-256-5175 Email : [email protected] LinkedIn : linkedin.com/in/shalman-m-0b5b45177 Keywords: information technology CSV specialist | Remote | Contract [email protected] |
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| Wed Apr 24 01:51:00 UTC 2024 |