- Reference: JLSCSV
- Location: South Wales
- Salary: Dependent on experience
- Type: Temporary
Just Life Sciences are seeking a CSV specialist who has worked within Med Tech or Pharma, this contract will last for a minimum 6 months and we are looking for the person to start within the next two weeks.
Qualifications, Skills and Experience
- Experience and purpose of role
·Strive to impart suitable knowledge around Computer Systems Validation
- ·Update the Site Validation Plan/s for all relevant sites (in relation to CSV activities).
- ·Lead, co-ordinate and drive all validation CSV project activities and agree timescales to successfully fulfil all CSV project validation requirements.
- ·Has a wide range of CSV knowledge and readily solves CSV related problems through feasible, practical solutions.
- ·Ensure timely reporting of identified and agreed Key Performance Indicators which support the validated state.
- ·Work to ensure the appropriate regulatory records are kept for validation
- ·Meet agreed targets for validation project completion as defined within each Project Plan
- ·Build a knowledge of CSV systems/procedures (and have a degree of understanding around the Design Control process).
- ·Contribute to the Design Control process on relevant aspects using CSV knowledge
- ·Continuously review and improve the Group CSV systems/procedures
- ·Work closely and communicate with project teams and relevant departments, such as R&D, QC, QA and Production, to fulfil all linked CSV requirements
- ·Support the relevant sites CSV requirements with a ‘hands-on’approach
- ·Understand Health & Safety regulations relevant to the organisational requirements
- ·Manage/Facilitate design review meetings for CSV systems, (having suitable process and risk knowledge).
- ·Contribute to project planning as required
- ·Identify and drive continuous improvement opportunities
- ·Maintain accurate and contemporaneous records of all validation work performed
- ·Prepare and review data and company documentation and technical reports as required
- This is an immediate start and if you are an experienced CSV consultant then please email your cv to justyn at justlifesciences dot com
Just Life Sciences
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