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Validation Specialist

Posted 17 days ago

  • Expiry Date: 29 May 2022

Job Description:

  • Apply FDA, MHRA, and other applicable global health authority regulations to the development of computer systems supporting regulated business processes.

  • Follow SOPs and industry best practices.

  • Possess Expertise on Good Documentation and Good Testing Practices, in order to train those within the business that are less familiar.

  • Facilitate the Computer system Validation Risk Assessment to identify governing regulations and validation deliverables during the development of the computer system.

  • Author/Review validation deliverables for projects which are contracted to third party suppliers.

  • Maintain close communication with stakeholders and team members to keep apprised of computerized system needs, impacts on computer validation, project validation status, and other relevant issues.

  • Assist in planning, implementing, and documenting user acceptance testing.

Review computerized systems validation documents such as:

  • Requirements Specification.

  • Design Specification.

  • CSV Risk Assessment.

  • Test Plans.

  • Test Summary Reports.

  • Data Migration Plan.

  • Pre/Post Executed Test Scripts.

  • Traceability Matrix.

  • Release to Production Statements.

  • Direct and review testing.

  • Provide guidance on quality issues that affect the integrity of the data or the system.

  • Obtain and respond to QA review.

  • Participate in establishing standard quality and validation practices.

  • Independently assess compliance practices and recommend corrective actions.

  • Approve validated computer system related change requests.

  • Monitor regulatory and inspection trends and advise the business on suitable action.

  • Ability to create documents to an existing document standard.

  • Able to develop all documentation required for a 21 CFR Part 11 validated project, including Validation Plans and Summaries.

  • Advanced knowledge of complete MS Office suite and Visio. Firm understanding of technology platforms as needed for project.

  • Experience with electronic document management systems (e.g. documentum, Qumas, SharePoint etc.); application development and

  • lifecycle management (e.g. HP ALM, JIRA, etc.); and IT service management systems (e.g. ServiceNow, SAP Solution Manager, etc)

  • Excellent oral and written communication skills in English. Strong expertise and ability to interview and accurately interpret communication requirements of team members

  • Once trained, have the ability to work independently on CSV projects with minimal oversight.

  • Ability to perform in a highly matrixed organization structure skills.

About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities.

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.