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