Csv Enginer

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- 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.