Description
CSV, Computer Systems Validation, IQ, OQ, PQ, FDA 21, GAMP5
Our client has a requirement for an experienced CSV Consultant to work on site for an initial 3 month contract based near Chester.
The successful CSV consultant will lead the preparation and execution of qualification protocols (IQ, OQ, and PQ) and associated execution documentation, eg Deviations, and all other CSV deliverables such as the Validation Plan, Requirements Traceability Matrix, Architecture Overview, and Design Specification, etc.
Key Skills:
- Lead and execute Computerised systems validation activities on site including defining the validation requirements and ensuring systems compliance to GAMP 5, along with the continuous regulatory expectations.
- Run Computerised systems validation project execution creating and executing validation packages in conjunction with relevant stakeholders, ensuring timelines are met and deliverables achieved.
- Proactively coordinate computerised systems validation activities and act as a central point of contact for the site for Computerised systems validation to ensure the projects are delivered on schedule.
- Take the lead role in the comprehensive validation/re-validation of the computerised systems highlighted in the inventory and to the priority, extent and scope defined in the aforementioned phased risk based approach.
Required Experience:
- Experience supporting computer system validation efforts including authoring computer system validation deliverables such as risk assessments, validation plans, test plans, test scripts and summary reports
- Experience in the preparation and execution of IQ, OQ, and PQ protocols
- Good knowledge of FDA 21 CFR Part 11 requirements, EU GMP Annex 11, and GAMP 5
- Understanding of SDLC (Software Development Lifecycle)
- Ability to work to project timelines and continually achieving project milestones
- Strong oral and written communication skills in English
- Proficiency in MS Office suite
- Open to creative, innovative, flexible and practical approaches to improving practices and solving problems
- Experience in supporting regulatory inspection and audits is preferred
For further information on the company and the role, please apply now by sending an up to date copy of your CV and contact details.
The IT Division of Morson International has an excellent track record in the supply of IT skills across the full IT life cycle. We have consistently supplied quality IT recruitment solutions whilst developing mutually beneficial, long term client relationships