Category: Information Technology
Location: Princeton, NJ
- 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
- 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.
Qualifications: 6+ years’ experience
- 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