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Project Manager - Validation and Data Integrity

Foster City, California
Job Title: Project Manager - Validation and Data Integrity
Location: Foster City, CA (work on-site)
Long-Term Contract position
The Project Manager will work on driving Data Integrity policies, principles and collaborating with CMOs and other business. 
Also, the person will work with pharmaceutical partners and platform providers to facilitate the development of remediation plans, training and support the execution of the plan.
 Perform Data Integrity assessments and document the results based on industry best practices
-  Develop training and procedures
-  Support, train, and execute a remediation approach that can be utilized across operations
-  Troubleshoot Data Integrity issues and come up with a solution
-  Develop Installation Qualifications based on Design
-  Develop Operation Qualifications based on functional requirements
-  Develop Performance Qualification scripts based on configuration
-  Route validation documentation and reports
Skills and Experience
-  7+ years’ experience in computer systems validation within the Life Science and Pharma industries in the areas of Quality Assurance, IT, and Manufacturing
-  Expert in Data Integrity and policies
-  Thorough understanding of the principles of computer systems validation, SDLC, VLC methodologies
-  Knowledge of cGxP, GDP, GAMP, 21CFR Part11, ALCOA 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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