Computer Systems Validation Specialist

Job type:
12 months
Real Staffing
South San Francisco
flag_no USA
project ID:

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Analyzes business problems to be solved with IT systems and processes. Provides analytical expertise in identifying, evaluating, designing and developing systems and procedures that are cost effective and meet user requirements. Configures some system settings and options; develops functional requirements and technical specifications. May provide consultation to users in the area of business systems and processes.

Additionally, performs validation of IT systems used in a GxP environment. Determines the scope of validation for GxP-impacting systems. Creates GxP deliverables such as Validation Plans, Risk Assessments, Installation, Operational and Performance Qualifications (IQ/OQ/PQ) protocols, test scripts, and Validation Summary Reports. Executes test scripts and documents test results in accordance with Good Documentation Practice. Ensures systems function as specified and in the event of deviations, performs root cause analyses and recommends corrective actions. Collaborates with Quality to ensure compliance with regulatory and procedural expectations.

  • In depth understanding of computer system validation principles, quality systems, and software engineering & design
  • Expert-level knowledge of regulatory expectations as they relate to GxP computer systems (e.g., 21 CFR Part 11, Eudralex Annex 11) and industry trends (e.g., GAMP 5)
  • In-depth technical knowledge of VMware 5.x
  • Excellent written and verbal communication skills
  • Adept at critical thinking
  • Excellent attention to detail
  • Strong ability to prioritize and plan competing assignments; able to frame approaches and timelines for project work
  • Able to work independently; can complete assignments well and on time without day-to-day instruction
  • Very collaborative and professional
  • 7 or more years of experience validating GxP client server applications, web applications and enterprise applications
  • Minimum BA or BS

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