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System Validation Analyst

Company: Anuva Resource Solutions
Location: Raleigh
Posted on: March 28, 2020

Job Description:

Position System Validation Analyst Location Raleigh , NC Contract Overview Ensures a compliant validation process is followed to deliver quality information technology systems which require formal validation. Create and manage system documentation and standard operating procedures. Partners with the project team to plan, test, and implement changes to ensure that the functionality and end-to-end solution conform to the required quality standard. Responsibilities Provides validation guidance to project teams from project initiation through post production deployment Suggests methods for the identification, implementation, recording and maintenance of the procedures, actions and documentation Creates, maintains, and secures compliance related documents Provides assistanceexpertise during system audits and periodic reviews Participates on cross functional teams to review and provide input into system compliance standards, procedures and guidelines Ensures systems are operational, validated and fit for purpose. Creates Validation Plans, Validation Reports and other validation deliverables as appropriate Coordinates, co - writes, reviews and releases Validation Documentation Acts as lead within a validation project team for Validation projects Adheres to, and recommend changes to validation documentation, SOP, Work Instructions and other related documents Participates in the continuous improvement of processes and quality Tracks corrective and preventive actions and improvement projects Advises on corrective and preventive actions Identifies and reports quality issues regarding applications and systems during periodic reviews Trainscoaches system ownersusers and validation team members on validation activitiestopics Minimum Qualifications Bachelor's degree or international equivalent 3 years of relevant experience Strong knowledge of validation standards activities Knowledge of GxP, GAMP, local regulatory guidelines Experience with company quality systems Demonstrable understanding of quality concepts, development methodologies, SDLC, and implementation standards Effective communication skills (written and verbal) Ability to interpret guidelines for system validation and follow instructions for validation

Keywords: Anuva Resource Solutions, Raleigh , System Validation Analyst, IT / Software / Systems , Raleigh, North Carolina

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