|Job Ref:||204814413||Employer:||cv-library.co.uk||Job Type:||Contract||Country:||United Kingdom||County/State:||Hampshire||City:||Southampton||Address:||Post Code:||SO14||Salary:||£550 - £600/day||Post Date:||19/10/2016 02:28|
A Computer Systems Validation is required for 12 months (likely to be extended) based in Southampton.|
The Computer Systems Validation will be required to provide Computer System Validation resource to R&D IT, promote and embed effective governance control and risk management processes that support business quality objectives and provide support and added value through pro-actively reviewing IT processes and standards to improve control environment, and to assure that the balance between risk and control is appropriate to business quality objectives. The Computer Systems Validation will be responsible for ensuring that documented evidence exists to provide a high degree of assurance that the operation and maintenance of all GR&D systems meet the required standards and Regulations and will participate and support Demand, Delivery and Service activities.
The Computer Systems Validation will have regulatory considerations of Requirements, Systems, Processes and ensures Requirements are appropriately specified and testable and will coordinate Business Criticality Risk Assessments and coordinate Supplier team through Risk Based compliance approach (Traceability Matrix and Risk Assessment). The Computer Systems Validation will develop Validation Plans and Test Protocols to define the approach to system verification and develop appropriate test scripts in conjunction with Business Users, Business Analyst, Application Analysts. Other duties will include -
* Review test results.
* Develop Testing Summary Reports, Release Notes.
* Support Change and Release Management.
* Maintain the Good Research Practice policies and procedures.
* Develops system Operating Procedures.
Experience/skills required -
Must have extensive experience of Computer Systems Validation (to GAMP5) in Pharmaceutical/Medical Device/Life Sciences industry
Expertise in US FDA (esp. 21 CFR Part 11) and UK MHRA Regulations, ISO Standards and GAMP5 Guide
Good understanding of Computer Systems Validation (GAMP5) and:
* Requirements gathering and documentation
* Risk Assessment and Management
* Traceability Matrices
* Change Management
* Configuration Management
* Supplier Assessment/Audit
* Validation planning, management and reporting
* Test planning, execution and management
ITIL: good understanding
Ideally, experience of one or more of:
* Integration and data management applications
* Data management, Data Standards
* Scientific Analytics, BI
* Content Management
* Enterprise Quality Management Systems
* Chromatography Data Management Systems
* Scientific data analysis tools
A Pharmaceutical/Life Sciences background is highly desirable.
This role is to start asap and will pay £(Apply online only) per day (depending on experience) Ltd/Umbrella