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Sr. Data Integrity / Validation Specialist

Foster City, CA · Biotech/Pharmaceutical
Title: Sr. Data Integrity / Validation Analyst
Type of role: Contract 12-24++ months
Location: Foster City, CA 94404

Job Description:
  • Candidate must have strong Data Integrity and compliance experience.  Must have superior knowledge of regulations relating to Data Integrity. 8+ years of Computer System Validation experience is strongly recommended
  • Experienced with Data Integrity programs (develop new approaches, assessments, suggest cGMP remediation’s/solutions)
  • Good understanding of computer system validation and computer system management in cGMP operations. (10-15 years)
  • Strong at analytics (analysis of agency-related warning letters, 483s, pattern recognition, prepare intelligence reports, metrics )
  • Perform Data Integrity assessments and document the results based on industry guidance.
  • Support, train, and execute a remediation approach that can be operationalized within client.
  • Work with facility Subject Matter Experts to document user requirements
  • Update application system User Requirements, Functional, and Design Specifications . Develop IQs based on Design . Develop OQs based on functional requirements . Develop Performance Qualification scripts based on configuration . Route validation documentation . Manage Tasks based on aggressive timelines . Interact with multiple stake holders . Interact in team environment
Qualifications:
  • 10-15+ years' experience in computer systems validation and Data Integrity preferably in the Pharma space .
  • Minimum BA / BS or relevant work experience in information systems, engineering, science or business.
  • Excellent oral and written communication skills.
  • Highly determined.
  • Ability to think through the task
  • Fast learner with evolving technologies
  • Thorough understanding of the principles of computer systems validation, SDLC, VLC methodologies .
  • Extensive Knowledge of cGxP, GDP, GAMP, 21CFR Part11, 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.
  • Strong communication and interpersonal skills ensuring the ability to interact with the business, peers and vendors in a professional manner.
  • Ability to work independently with minimal supervision.
Dawn West
AdeptSource
 
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