Quality & Regulatory Officer
Wednesday 16th November 2022
Overview of role:
We are recruiting for a Quality & Regulatory Officer for our client, a leading medical supply company based in Wicklow.
This excellent opportunity has arisen due to company growth. The successful individual will be responsible for supporting the Quality Management system.
- Coordination of product recalls and complaints including reporting to HPRA and suppliers
- Support new product set-up processes
- Respond to medical information requests received from customers & support customer services queries
- Perform and report the temperature mapping, monitoring, calibration, and shipping validations
- Support training of personnel in Good Distribution Practices, Standard Operating Procedures and Quality System requirements
- Preparation and submission of data for monthly, quarterly, and annual reports (KPIs), and assist with management review preparation
- Responsible for maintaining the Internal & External (Supplier) Audit schedules
- Assist with the preparation for and participate in regulatory and customer audits
- Maintain good professional working relationships both internally and externally to the business.
- Provide cover for other team members as required
- Relevant Third Level qualification
- Experience in a Quality Assurance/Regulatory role essential
- Experience in GMP, GDP and ISO environments
- Experience of regulatory body liaison e.g. the HPRA, MHRA
- Working knowledge of Irish medicines regulations desirable
- Auditor Certified (e.g. ISO 9001)
- QMS software systems experience
This is a full-time, permanent position with salary range of €40k to €45k, with bonus and pension