Quality Control Manager

Our client is a global innovator organisation with core competencies in the fields of pharma, biotech, medical devices and diagnostics to name but a few. Employing upwards of 30,000 people worldwide, this organisation sets trends in research-intensive areas with their products and services designed to benefit people and improve their quality of life.

The Role:

Our client is currently seeking a Quality Control Manager to be part of their fast paced team based at their facility in the West. You will be managing a team of analytical staff and you will ensure all company activities, objectives and KPIs are met you will be focused on the area of Quality Control Management.

Your key responsibilities as Quality Control Manager will be to:

  • Co-ordinate and manage all analytical staff and activities within the QC laboratory ensuring all activities are carried out manage and co-ordinate QC sampling routines for API, Utilities and final product with preparation of relevant QC documentation including protocols, reports, analytical data sheets, SOP’s, change controls, deviations and IRF’s.
  • Review and approve departmental validation protocols, reports, including filled products, raw material and stability analytical data sheets. Review and approve ono-chromatographic and chromatographic data.
  • Co-ordinate and manage any laboratory investigations and approve any retesting required. Ensure that they are documented correctly and closed out in a timely manner.
  • Manage the stability testing program, ensuring any issues are promptly communicated.
  • Manage the department purchase of equipment and materials and ensure availability of all materials required for testing.
  • Manage and co-ordinate with Engineering and external instrument calibration/maintenance companies to maintain QC instrument calibration and maintenance to specified schedules.
  • Manage the investigation and documentation of any retesting in the QC laboratory.
  • Manage contract laboratory testing laboratories, ensuring compliance to GLP and agreed testing deadlines and costs.
  • Adhere to all company and legislative EHS requirements. Support and implements EHS programmes and initiatives.

The Person

  • Minimum of a Scientific Bachelor’s degree (preferably Chemistry) with 5+ years’ experience of sterile products in a pharmaceutical company.
  • Must possess process and manufacturing knowledge of sterile processes
  • Capability to manage team, set clear goals, communicate clearly and ensure progression to completion.
  • Development and training of team members and management of resources and budgets.

The Benefits:

  • Pension
  • Health Insurance
  • Bonus

To learn more apply online or contact Orla Boyle at HRM directly on +353 91 782110 for a confidential chat.

Salary: On Application Location: Galway