Computer System Validation Specialist
Computer System Validation Specialist
Posted on :
13-10-2024
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Job Description
Job Title: Computer System Validation Specialist
Location: Remote
Role and Responsibilities:
- Possess handson experience with the Veeva Vault QualityDocs 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 multifunctional 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).
- 7 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.
- Handson experience validating and maintaining the Veeva Vault QualityDocs system and data migration.
- Understanding of GAMP 5 techniques software industry standards and their implications on internal procedures and software quality.
Employment Type
Full Time
Key Skills
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