Category
Location
Type

Quality Assurance

Quality & Regulatory Officer

Posted on:

Wednesday 16th November 2022

Overview of role:

Description:

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.

Responsibilities:

  • 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

Requirements:

  • 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

Salary:
See description

Closing date:
31/12/2022

Reference number:
DL/PM2