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Sr. Project Manager - Validation and Data Integrity

Foster City, California
Job title: Sr. Project Manager - Validation and Data Integrity
Location: Foster City, CA (work on-site)
Long-Term Contract position
Work with pharmaceutical partners and platform providers to facilitate the development of remediation plans, and train and support the execution of the plan.
-  Perform Data Integrity assessments and document the results based on industry best practices
-  Support, train, and execute a remediation approach that can be utilized across operations
-  Work with Subject Matter Experts to document user requirements
-  Update application system User Requirements, Functional, and Design Specifications
-  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 and interact with multiple stake holders
Skills and Experience
-  10+ years’ experience in computer systems validation within the Life Science and Pharma industries in the areas of Quality Assurance, IT, and Manufacturing
-  Thorough understanding of the principles of computer systems validation, SDLC, VLC methodologies
-  Knowledge of cGxP, GDP, GAMP, 21CFR Part11, Annex 11, MHRA guidance, and industry best practices
-  Understanding of existing and new business processes and requirements to ensure proper implementation and validation of systems
-  Strong communication and interpersonal skills interacting with business, peers, and vendors
-  Consistently meet the agreed quality and time goals

Education: BA / BS information systems, engineering, science or business
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