Description
For one of its clients, a pharmaceutical company located in Walloon Brabant, Harvey Nash is currently looking for a IT Compliance Consultant
Duration: 6 months
Location: Walloon Brabant
Scope of work:
- Review and approve key documents as defined in the IT Validation procedure for IT Systems
- Ensure that the documents align with IT standards and IT and Business strategies.
- Review and approve Change Requests for IT Systems
- Liaise between the business and IT validation department
- Process Improvement for these compliance activities.
- Validation of business tools.
- Review IT processes.
- Provide advice and guidance on compliance issues.
- Responsible for the IT Tools and System Inventory, ensuring that all IT systems used within the department are successfully validated if needed, documented and that all problems are resolved.
- Tracking key audit findings to support resolution.
- Promoting visibility of validation through the department
- Support Business Operations Team with IT Tools
- Actively participate in the department Centre of Excellence and projects
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- Launch a review of the risk-based approach to IT systems validation. Lead workshop sessions to analyse and define improvement objectives and current good practice. Drive optimum validation approach.
- Evaluate and design shared process for computer system supplier assessments and audits, co-ordinate resource and process across all groups.
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- Work with PV (Pharmacovigilance) to ensure that changes to system descriptions, whether definite or implied, are changed in its' description in the PSMF (Pharmacovigilance System Master File)
- Development of business tools.
- Attend Steering Committee Meetings.
- Attend Global Applications Board Meetings and provide summary to senior management.
- Attend IT Compliance Centre of Excellence Meetings.
- Attend IT/QA meetings.
- Attend Technology meetings.
- Perform Supplier Audits
- Provide other assistance as required.
Requirements:
- Knowledge of regulations used in the pharmaceutical industry
- Fluent English
Tags: CSV, computer system validation, validation, IT compliance
Harvey Nash is a trusted partners of several international pharmaceutical companies.