Our client is a global pharmaceutical leader that focuses on improving patient's lives by identifying, developing, and commercialising meaningful products that address unmet medical needs. Since their founding, they have focused on putting the patient first and this remains their priority as they continue to develop, acquire, and commercialise new treatment options for patients with challenging conditions that no one else is tackling. Currently employing over 40,000 staff globally, with offices in the U.S. and Europe, they are a continually expanding company with a broad portfolio and a very healthy pipeline. This organisation has an incredible manufacturing footprint here in Ireland, with one of their plants currently in need of a Quality Control Manager (Analytical) to join their operation.

The Role

The Quality Control Manager will work with the Senior QC Manager and the QA Department to represent the Quality Control laboratory during audits from regulatory and corporate authorities.

Key responsibilities would include:

• Responsible for the management and performance of the Analytical Quality Control Laboratory and for providing analytical expertise and support to the site as required.
• The QC Manager will also manage the QC Laboratory resources to meet plant schedules and budgets.
• Manage and co-ordination of QC sampling routines for API, utilities, and final product with preparation of relevant QC documentation including protocols, reports, analytical data sheets, SOPs, change controls, deviations and IRF.
• Review and approve departmental validation protocols, reports, including filled product, raw material, and stability analytical data sheets. Review and approve non-chromatographic and chromatographic data.
• Manage and co-ordinate with engineering and external instrument calibration / maintenance companies to maintain QC instrument calibration and maintenance to specified schedules.

The Person

• Min level 8 degree in science-related discipline (preferably chemistry).
• 5 years' experience in pharmaceutical industry within Quality Control.
• People management is advantageous for this position.
• Experience working with regulatory authorities - FDA, HPRA.

To discover more about this opportunity, apply now or contact Déanna Healy at HRM Search Partners on +353 87 6369263 for a confidential discussion.