Computer System Validation Engineer

I have an excellent opportunity available in the San Diego area for a Computer System Validation Engineer at a well established medical device company.

Requirements:

* Review and approval of documentation for validation and qualification activities to support computer systems validation of GXP software systems.
* Quality Assurance review of validation deliverables in support of computer systems/equipment validation for stand-alone and enterprise systems
* Reviewing of computer system documents and providing guidance to project teams
* Knowledge of GAMP, Risk Based approaches in validation for laboratory systems
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Conducting System Compliance Assessment
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Developing and managing GxP system lifecycle documentation, including Validation Plans, User Requirements Specifications, Functional and Design Specifications, Testing Protocols (IQ/OQ/PQ), Traceability matrix, Validation Reports, SOPs, Change Control Documentation, and Risk assessment reports
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Reviews completed protocols for completeness, cGxP compliance and data acceptability; compiles final datapack.
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Initiate and enforce necessary improvements and corrections to established systems and processes via mitigation plans and change control If you meet the above requirements please respond ASAP to be considered for an interview
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