IT Validation Manager
|Job Title:||IT Validation Manager|
|Location:||Kingston Upon Hull, East Riding of Yorkshire|
|Salary:||£400.00 - £450.00 per day|
|Contact Name:||John Wright|
|Job Published:||September 18, 2018 11:11|
The Consultant IT Computer Systems Validation Manager is to ensure that the global IT organization is in compliance with all applicable healthcare laws and regulations with a focus on computer systems validation. The role requires good communication skills to be able to work with a wide variety of IT and non-IT staff at various sites around the world.
The Consultant IT Computer Systems Validation Manager is also responsible for coordinating and facilitating internal and external audits of IT. In this role it is necessary to work with auditors in addition to Regulatory, Quality, Finance, IT and other personnel as required. Post-audit requirements include following up on audit findings and working with the appropriate staff to remediate all findings
- 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)
- 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
Is this exciting opportunity of interest? If so, please apply and I will be in touch ASAP.
Lawrence Harvey is acting as an Employment Business in regards to this position.
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