East Riding of Yorkshire, England
£450 - £500 per day
about 1 month ago
- Interim IT Validation Manager - £450-500p/d
- East Riding of Yorkshire
An Interim IT Validation Manager at £450-500p/d is required for a FTSE100 Manufacturing organisation based in East Riding of Yorkshire. A 3 month contract, likely to extend, this is an exciting opportunity within managing IT quality for Computer systems and software, using cloud computing as well. This is a fantastic opportunity to develop your experience in a mature function with a company who are world leaders in their field.
- 60% Provide consultation and governance in the areas of regulatory requirements and Computer System/Software Validation
- 20% Coordinate and manage global IT efforts toward compliance with the Quality System Regulation and non-product Computer Software Validation in compliance with regulations such as FDA CFR 21 Part 820 / Part 210 / Part 211 / Part 11 and ISO 13485. This role includes advising IT and the user community what falls under these regulations and helping to coordinate efforts toward compliance with them
- 5% Work with internal and external auditors to facilitate all IT components of regulatory audits. This includes setting up schedules, providing work spaces, acting as the facilitator and escort for audits, and working with global sites to plan and execute audits at individual sites.
- 5% Perform internal and/or external audits of IT sites to insure compliance with IT CSV procedures and applicable regulations.
- 10% Support and adhere to all IT policies, procedures and standards, including but not limited to, IT Guiding Principles, Project Management, Change Management, Internal and External Compliance such as Health & Safety, Quality, Regulatory and Finance, and support of Internal and External Audits
- At least 12 years in Information Technology, with at least 5 years of that in supporting and/or managing IT Quality Computer System/Software Validation delivery and oversight.
- Significant experience of Cloud computing in a healthcare environment, computer systems validation within an Agile environment and the GAMP 5 framework
- Validation of IT computer systems is focused on complex business systems such as SAP rather than (Laboratory systems or Production line systems)