Requirements

• Processing of MHRA import notifications and subsequent acknowledgements, inc. objections and further information requests
• Processing HPRA exempt medicinal product notifications
• Ensure cover for all operational daily Quality Compliance duties in co-operation with colleagues.
• Creation and maintenance of Quality Compliance ERP components
• Internal and External processing of special clinical needs letters and in-house authorisations.
• Respond and support the business requests for document updates, document obsoleting and document archiving in eQMS
• Maintain the Document Processing and Document Management associated work instructions
• Keep training matrices relevant and up to date.
• Ensure employee names, roles and reporting structure is current within the LMS
• Respond and support the business requests for the creation of all courses for the SOPs & Policies from the eQMS and other Clinigen training courses
• Ensure training material is correct and current.
• Provide reports of compliance status of training records.
• Act as an LMS admin for Clinigen and provide training to local LMS admins across the Global Clinigen sites
• Maintain oversight of GxP training compliance and annual review and update of training material
• Create and maintain the process on how to report monthly training for GXP training compliance status to identify gaps and overdue training.
•