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
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 appraised of computerized system needs, impacts on computer validation, project validation status, and other relevant issues
Assist in planning, implementing, and documenting user acceptance testing
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
Review computerized systems validation documents such as:
CSV Risk Assessment
Test Summary Reports
Data Migration Plan
Pre/Post Executed Test Scripts
Release to Production Statements
6+ years’ experience
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.
Possess Expertise on Good Documentation and Good Testing Practices, in order to train those within the business that are less familiar.
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
3 years experience in Computer System Validation
3 years of ALM
3 years of CSV Documentation author and review, approve
1-2 years of experience in Change Control
Should be able to work with minimal supervision
Experience/understanding of Data Integrity concepts
Understanding of GAMP categories and validation approaches