Global Quality Assurance Executive III

Location: Galway, Republic of Ireland
Salary: Negotiable
Posted: almost 2 years ago
Role type: Permanent
Industry: Life Sciences & Engineering Practice, Science Leaders & Specialists
Contact name: Aidan Toner
Contact email: aidan.toner@hrmrecruit.com

Job description

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.

The Role:

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 Person:

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.

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