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Project IT Compliance Manager - GAMP, GxP, Document Management
Have you worked in a Pharmaceutical or Healthcare environment as an IT Quality, Risk and Compliance Manager supporting applications upgrade projects? Do you have ITQMS knowledge and document management skills? The this could be for you.
My client is a leader in global healthcare and is currently looking for a Project IT Compliance Manager to support the business across multiple IT projects and applications upgrades.
The core need is for an IT Quality, Risk and Compliance Specialist to initially work on the upgrade of a document management system ( Documentum ) in a healthcare manufacturing environment ( GAMP, GxP )
The role will be to lead around IT Compliance for all projects and encompass:
- Ensure awareness, efficiency & integration of Risk Management & Quality within the IT teams.
- Support Global IT in all matters relating to the management of documentation & records, ensuring that IT functions follow documentation policies / plans / strategies are compliant with current policies
- Contributing to the success of change control and project delivery through continuous engagement and close alignment with IT System Owners, Project Managers and Business process Owners.
- Prepare and Support audit readiness of applications under area of responsibility
- Compile agreed metrics to monitoring changes and projects to drive improvements in compliance.
- Support corporate initiatives to improve existing IT compliance, interpreting the policies to promote a pragmatic level compliance that is justified by the risk to the business.
- Represent IT Compliance in project teams developing new applications, as well as changing to existing applications and the management of additional compliance resources.
- Have opportunities to work with international colleagues and on multiple platforms.
- Play an important part in ensuring that applications are developed, maintained and decommissioned in accordance with industry best practice and internal standards.
- Proved experience of regulatory compliance management of business systems in a changing environment.
- Detailed understanding of IT Lifecycle Management, Change Control, Testing
- Practical regulatory knowledge GAMP, GxP and basic GDPR
- Test management including the use of testing tools e.g. HPQC
- Change management and communication skills
- Manage system lifecycle documents currently Documentum, Mulesoft and e-Commerce but could
- Contribute at change board as approver of changes
- Support the IT teams in preparation of changes
- Support the PMO process as required including planning and the management of contingent Validation staff.
- Champion the adoption of HP Quality Centre for Testing
- Champion the adoption of HP Quality Centre for Requirements and traceability
- Implement IT QMS Best Practices re-usability and quality & Compliance controls
If you can show multiple instances of the practical application of these required skills and experiences then please apply!
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