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The Quality Systems Manager is responsible for ensuring that PrimeVigilance’s electronic Quality Management System (eQMS) is used optimally by the business and that it meets PrimeVigilance and the Client’s needs and regulatory requirements.
The Quality Systems Manager will have oversight of the PrimeVigilance electric Quality Management System (eQMS), including any core quality systems. They will work closely with the Head of Quality, Associate Director of Quality Management, Senior Quality Manager CSV and IT group to ensure all aspects of PrimeVigilance eQMS are maintained to meet PrimeVigilance and Regulatory requirements.
The Quality Systems Manager will be the expert in understanding PrimeVigilance’s and its Client’s needs of the eQMS and ensuring a robust and compliance system is maintained to meet the company’s requirements.
The Quality Systems Manager will work closely with the vendor to understand recommended best practice, escalate support issues and learn of and implement new features that would benefit the business.
Responsibilities include but are not limited to:
· Become a Subject Matter Expert on PrimeVigilance’s quality systems and provide support where possible.
· Ensure the eQMS is maintained in a validated state, as required by PrimeVigilance and its clients and that routine upgrades are successfully managed
· Lead business continuity planning and testing activities for the eQMS
· Ensure the eQMS system is audit and inspection ready and support audit and inspections activities as required
· Support Users and Quality Team to ensure that the eQMS is optimised to support PrimeVigilance’s Quality Management System
· Analyse PrimeVigilance’s processes and propose and drive system improvements and efficiencies.
· Form strategic partnerships with IT and operations to identify and implement system enhancements and drive Quality and IT to implement.
· Being a change champion to ensure that improvements in system functionality are implemented in a timely fashion
· Support the Quality Management and Learning and Development teams with authoring, reviewing and approving relevant procedures and trainings
· Create and maintain procedures related to eQMS. Support the Associate Director of Quality Management and Head of Quality with other activities as necessary
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