About the Company: An American contract research organization providing comprehensive, integrated drug development, laboratory, and lifecycle management services.
Benefits: Real Staffing offers medical, dental, vision, 401K, voluntary life insurance, short term/long term disability.
Your Main Responsibilities:
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.
Basic Qualifications:
3-5 years of CSV script and document quality review experience
3 years of HP ALM
3 years of CSV Documentation
2-3 years of experience in Change Control
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)
Sthree US is acting as an Employment Business in relation to this vacancy.
