Our client is a leading multinational generic pharmaceutical company, with operations in Galway. The organisation's 40,000 staff work hard every day to provide high-quality medication to the world's 7 billion people. 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.
As the Quality Assurance Executive, you will be responsible for:
- Reviewing batch affiliate and TPM documentation for US Market shipping and distribution.
- Investigating and reviewing product complaints and escalations, stability OOS and non-conformances of products manufactured and released from local site, TPMs and vendors.
- Timely closure of CAPAs.
- New vendor or new TPM assessment, approval and maintenance including authoring of Technical Agreements.
- Authoring, reviewing and approving Change Control/Deviation for affiliates and vendors/TPMs.
The ideal candidate will have:
- Equivalent scientific qualification (ideally in life science or pharmacy).
- 5 - 8 years' relevant medical device or pharmaceutical experience.
- Minimum 2 years' experience in a quality assurance role.
- Experience working with Pharma Quality Management Systems.
- Experience of Quality Risk Management.
- Knowledge of cGMPS i.e., USFDA, 2003/94/EC, MHRA and WHO.
- Ideally, experience working in a highly regulated sterile manufacturing environment.
To discover more about this opportunity, apply now or contact Aidan Toner on +353 91 782 110 for a confidential discussion.