- Work with project manager and client personnel to understand overall project objectives.
- uthor validation plans, user requirements documents and/or system requirements documents, configuration/design specifications, risk assessments, test protocols, traceability matrices, data migration plans, and change records.
- uthor and review testing plans and scripts (IQ/OQ/PQ), execute test plans and scripts, prepare test summary reports, and prepare final validation reports.
- Manage and maintain electronic records in client's document management system to demonstrate compliance with government issued regulations.
- Support maintenance and enhancements for the client's custom integration between Veeva QualityDocs and Cornerstone.
- Consult with client personnel to ensure that the validations activities and deliverables meet client corporate policies and procedures.
- degree from an accredited, four-year college or university; advanced degrees and certificates/certifications are highly desirable (e.g., PMI-PBA, CAPM, PMP)
- t least 5 years of relevant work experience in a computer system validation (CSV) role in the biotech/pharmaceuticals industry; knowledge of applicable regulations and guidance (e.g. Title 21, GxP) is highly desirable.
- t least 3 years of relevant work experience with Cornerstone On Demand. Bonus points for experience in Compliance Wire, Veeva Quality Docs, SQL and python
- Be grounded in solid project management and system validation methodology and set and manage expectations extremely well.
- Be able to handle multiple projects and competing priorities with a proven track record of quality results.
- Thorough understanding of a Risk Management-Based Approach to system validations including system risk categories and system class (GAMP 5).
- Working knowledge of 21 CFR Part 11 and Annex 11.
- Understanding of regulations around personal and patient data privacy (GDPR).
- Experience leading a validation project.
- Experience authoring validation plans, user requirements documents and/or system requirements documents, traceability matrices, testing plans and scripts (IQ/OQ/PQ), executing test plans and scripts, preparing test summary reports, and preparing final validation reports.
- Experience using Electronic Document and Quality Management Systems such as Veeva, Qualio, or Master Control is highly desired.
- Experience with test coordination and testing management, include training users on executing test protocols and managing test results through the process.
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