Supplier Quality Executive II

My 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:

My client is currently seeking a Supplier Quality Management Executive II for a contract duration of 9 months to be part of their fast paced team of seven based at their facility in the West. You will have quality oversight on third party partners who manufacture compliant and high quality product.

Key Responsibilities:

  • Support release of Third Party Manufactured products, by review of batch documentation.
  • Review Third Party Manufacturer’s Deviations and Incident Reports.
  • Prepare and assess Change Control documentation from Third Party Manufacturer’s.
  • Support Annual Report submissions for Third Party Manufacturer’s.
  • Prepare Annual Product Quality Reviews for Third Party Manufactured Products.
  • Review and approval of artwork change controls.
  • Review stability protocols and reports.
  • Performing Third Party Manufacturer and API supplier risk assessments.
  • Support the Management of the Vendor Approval System.
  • Preparation of SOP’s, Technical Agreements and Confidentiality Agreements.
  • Maintenance of Product Technical Files.

The Person:

The ideal Supplier Quality Management Executive II will possess the ability to apply themselves to the tasks at hand in a fast paced environment:

  • Minimum Bachelor’s degree (or equivalent) in a life science or pharmacy and 3-5 years of experience in quality function within a pharmaceutical company.
  • Experience of sterile injectable manufacturing and supplier quality management desirable but not essential.
  • Knowledge of Pharmaceutical QMS Systems and Quality Risk Management Systems.
  • Knowledge of cGMPS i.e., USFDA, 2003/94/EC, ICH Q7 and WHO.

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

Salary: On Application Location: Galway