Operational Quality Specialist Lead

4 days ago

Cork, Cork, Ireland TN Ireland Full time
Job Description

The Operational Quality Specialist will provide quality oversight and support to activities related to Quality Systems across the site, ensuring compliance with regulatory requirements. The role involves collaborating with cross-functional teams to deliver process improvement initiatives.

  • Develop and implement Quality Management Systems to ensure a robust quality management framework.
  • Provide expertise in Quality Notifications/Investigations/Change Management; environment monitoring programs; sterility assurance/low bioburden manufacturing; etc.
  • Use knowledge to improve Quality Systems and/or Operational Quality; solve complex problems, provide continuous improvement and execute tasks.
  • Act as a resource to colleagues with less experience in Quality Systems and/or Operational Quality.
Requirements

This role requires:

  • Degree or 3rd level qualification (Science, Quality).
  • Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation.
  • 5 years' experience in the pharmaceutical industry or a similar operating environment which includes experience in a Quality function.
  • Quality Assurance SME knowledge, from both operational and educational experience, is required.
  • Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance.
  • Stakeholder management of multiple decision makers, auditors, cross-functional teams by demonstrating the ability to maintain and strengthen trust relationships with people at all levels.
Benefits

The successful candidate will enjoy:

  • A competitive salary package.
  • The opportunity to work in a dynamic and collaborative team environment.
  • Ongoing training and development opportunities.

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