Quality Assurance Executive

This leading generic and specialty pharmaceutical company maintains one of the industry’s broadest and highest quality portfolios. With more than 1,400 high quality generic, branded and over-the-counter products, they cover virtually every dosage form and therapeutic category, from cardiovascular, osteoporosis and gastro-intestinal diseases, to central nervous system, antihistamines, diabetes and antibacterial. With over 30,000 employees worldwide and a revenue of almost $12 billion in 2017, this company is passionate about providing quality health care to the world’s 7 billion people, one person at a time. The company’s most recent Irish expansion outlined an annual investment of up to €76 million ($100 million). Due to this continued growth of the company in Ireland, a role has arisen for a Quality Assurance Executive to be based in their state of the art facility in the West of Ireland.

The Role

The Quality Assurance Executive will be responsible for:

  • Reviewing batch documentation from affiliates and TPM’s, including associated deviation / incident reports
  • Ensure CAPA’s are closed in a timely manner
  • Investigation and review of product complaints and escalations, stability OOS and non-conformances
  • Reviewing and assessing Change Control’s received from affiliates and TPM’s
  • Preparing annual product quality reviews for third party manufactured products and support annual report submissions
  • Review of validation and stability protocols and reports
  • Manage complaints receipt and review investigation and responses

The Person

The ideal candidate will have:

  • Minimum BSc in a Life Science or Pharmacy
  • Minimum 3-5 years’ experience in quality control or quality assurance within a pharmaceutical company
  • Excellent communication skills, both verbal and written with a proven track record of working in cross-functional and multi-disciplinary teams
  • Experience of sterile injectable manufacturing and supplier quality management desirable but not essential

To discover more about this opportunity, apply now or contact Maeve Fahey at HRM on +353 1 6321885 for a confidential discussion.

Salary: On Application Location: Galway