Description : Global Quality Assurance are in the process of reviewing the expansion of Norgine’s document management system and are also in the process of implementing a departmental SharePoint site to manage users’ permissions to electronic systems.
We require support with activities relating to these two projects.
To act as business administrator for Norgine’s Quality Management System (eQMS TrackWise and eGSOP ComplianceSP ). Maintain eGSOP and eQMS ensuring they remain fit for purpose’ and adaptable to changing business needs.
Requirements / Qualifications :
Science or computer science graduate or currently undertaking a course
Interest in Quality Systems and the Pharmaceutical Industry
Good organisational, communication and presentation skills
Proficient in Microsoft Office (advanced) and ability to learn new applications
Ability to solve problems and critically analyse proposed solutions
Ability to write reports.
Ability to prioritise tasks and deliver against milestones in a fast paced environment
The job holder will be expected to comply with Norgine policies and procedures and local regulations as appropriate
Develop an overview of the pharmaceutical industry and drug development process
Develop an understanding of electronic Quality Management Systems and insight into the corporate working environment
Responsibilities : Key Accountabilities & Responsibilities
Gain hands on experience on those processes needed for eQMS and eGSOP functionality (TrackWise) ensuring they are established, implemented and maintained.
Opportunity to implement changes to both electronic systems as per Norgine’s computer testing and validation processes.
Develop effective training and design training tools related to quality processes.
Produce reports on the performance of the Deviation / CAPA processes and controlled document periodic reviews, highlighting any need for improvement using KPIs.
Support specific Quality Management System projects as required.
Close collaboration with Global Quality, IT and cross-functional teams depending on the nature and stage of the projects.
Interaction as required with external service providers such as expert consultants