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- 2 plus years' experience
- 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.
- 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.
- SAP: 3 to 5 years
- Attention to detail, work ethic: 3 to 5 years
- Excellent Communication: 3 to 5 years
- oral and written communication: 3 to 5 years
- 2 plus years of experience in managing the projects as CSV specialist /lead.
- 2 plus years of experience in testing , (script reviewing from a QA perspective in particular )
- 2 plus years of experience in authoring, reviewing various validation documentation such as (Val plan, Risk assessments etc.)
- 2 plus years with 21 CFR Part 11 experience.
- Prior BMS experience
- Prior ERP experience
- PM skills highly preferred
- Great oral and written skills
- Organized and lead a lot of high visibility project preferred.
- ID: #50006803
- State: New Jersey Princeton 08540 Princeton USA
- City: Princeton
- Salary: USD TBD TBD
- Job type: Permanent
- Showed: 2023-05-27
- Deadline: 2023-07-25
- Category: Et cetera