"6+ years experience
• Apply FDA, MHRA, and other applicable global regulations to the development of computer systems supporting regulated business processes
• Follow SOPs and industry best practices
• Conduct training on good documentation and good testing practices
• 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:
o Requirements Specification
o Design Specification
o CSV Risk Assessment
o Test Plans
o Test Summary Reports
o Data Migration Plan
o Pre/Post Executed Test Scripts
o Traceability Matrix
o Release to Production Statements
• Direct and review testing
• Provide guidance on quality issues that affect the integrity of the data or the system
• Prepare validation summary and test summary reports
• 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
• Advanced knowledge of complete MS Office suite and Visio. Firm understanding of technology platforms as needed for project.
• Ability to create documents to an existing document standard.
• Working knowledge of Documentum.
• Excellent oral and written communication skills in English. Strong expertise and ability to interview and accurately interpret communication requirements of team members.
• Able to develop all documentation required for a 21/11 validated project, including Validation Plans and Summaries.
• Experience in producing software documentation and business requirement documentation (minimum 3 yrs); experience with Software Development Life Cycle Management and CFR 21 Part 11 compliance."