Title: Sr. Data Integrity / Validation Specialist
Type of role: Contract 12+ months
Location: Foster City, CA
Candidate must have 10+ years of Validation experience along with a Data Integrity background, compliance experience and have superior knowledge of regulations relating to Data Integrity.
Experience with assessment and remediation
Perform Data Integrity assessments and document the results based on industry guidance.
Work with clients internal partners to facilitate the development of remediation plans, train, and assist with the execution of the plan
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+ 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.
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.