Sr Validation / Data Integrity Compliance Consultant

Location: Foster City, CA
Date Posted: 12-28-2018
We are seeking a Senior Validation / Data Integrity Compliance Consultant. Must have strong experience with Data Integrity Compliance.
 
Duration: Long-term Contract (C2C, 1099, or W-2)
Location: San Francisco Bay area, CA (onsite)
 
Data Integrity:
  • Perform Data Integrity Assessments and Document the results based on industry guidance
  • Work with Partners to facilitate the development of remediation plans, train, and assist with the execution of the plan
  • Support, Train, and execute Remediation approach that can be operationalized with the company
Validation:
  • Work with facility Subject Matter Expert to document user requirements
  • Update application system user requirements, functional, and design specification
  • Develop installation qualifications based on design
  • Develop operation qualifications based on functional requirements
  • Develop performance qualification scripts based on configuration
  • Route validation documentation
  • Manage tasks based on aggressive timelines
  • Interact with multiple state holders
  • Interact in Team environment
 
Requirements:
  • 10-15 years’ experience in Computer Systems Validation within the Life Science area, preferably in the Pharma space
  • BA/BS or relevant work experience
  • Excellent oral and written communication skills
  • Thorough understanding of the principles of CSV, SDLC, VLC methodologies
  • Extensive knowledge of GXP, GDP, GAMP, 21CFR Part 11, Annex 11, MHRA guidance and industry best practices
  • Ability to understand existing and new business processes and requirements to ensure proper implementation and validation of systems
  • Ability to work independently
  • Consistently meet the agreed timelines with high level of quality
  • Some travel may be required on occasion
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