​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 in 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

• 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

Responsibilities:

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

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.