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Job Location | Glasgow |
Education | Not Mentioned |
Salary | £45,000 - £55,000 per annum |
Industry | Not Mentioned |
Functional Area | Not Mentioned |
Job Type | Permanent , full-time |
We are currently looking for a CSV Specialist to join a leading biotechnology procurement consultancy company who have developed a state of the art software which enables biotech companies to streamline their procurement process who are based in the Glasgowarea. As the CSV Specialist you will be responsible for the entire life cycle of system and software validation in both lab practices and manufacturing practices.KEY DUTIES AND RESPONSIBILITIES:Your duties as the CSV Specialist will be varied however the key duties and responsibilities are as follows:1. Assessing software/system functionality and identifying areas requiring validation and complete detailed risk assessment to identify potential areas of non compliance within the software and systems. 2. Working on the Validation life cycle, strategy, protocol design and testing of softwares and systems across the procurement systems.3. Collaboration between customers, inventory on boarding, and other internal teams to ensure synchronised efforts throughout projects.4. Staying updated on relevant industry regulations, standards and guidelines to ensure that validation processes and methodologies are updated and adhere to industry best practices.ROLE REQUIREMENTS:To be successful in your application to this exciting opportunity as the CSV Specialist we are looking to identify the following on your profile and past history:1. Relevant degree in a Scientific or technology based subject.2. Proven industry experience in Life science or Biotechnology (Or similar)3. A working knowledge and practical experience in validating GxP software systems, applying relevant guidelines and regulations to maintain validation compliance and comprehensive knowledge of regulatory requirements including FDA 21, CFR Part 11Key Words: CSV , Computer system validation , GxP , regulations , Specialist