Quality Specialist

  • Contract
  • Cork

Website TPM05240

A Quality Specialist is required for a biopharmaceutical in West Cork. The successful candidate will be accountable for the Quality Systems within the site. This role requires the delivery of a robust Quality Management System to support a flexible, collaborative, multi-skilled teamwork environment. The Quality Specialist will have proven capability in development of Quality Systems.


  • Provides to the site knowledge and experience in Quality Systems.
  • Uses knowledge to improve Quality Systems, solve problems, provide continuous improvement, and execute tasks.
  • Provides compliance contribution to project teams and leads small projects.
  • Coaches and guides colleagues within the site.
  • Understands and applies regulatory / compliance requirements to their role together with remaining current on upcoming regulatory and compliance changes.
  • Responds to non-standard requests from customer needs.
  • Makes decisions within guidelines and policies which impact own priorities and allocation of time to meet deadlines.
  • Supports Corporate Quality to ensure actions related to Quality Systems at the site are executed.
  • Participation in inspections of Site by Divisional / Regulatory Bodies / third parties together with follow up actions where applicable.
  • Participation in and leading internal inspections
  • Participate in GMP Walkthroughs.
  • Deviation Management & Change Control approval.
  • Ensures supply of high-quality product through the implementation and oversight of the Quality Management System for the site.
  • Champion the highest Quality and Compliance standards for the site.
  • Ensure highest safety standards.

Qualifications & Experience:

  • Degree or 3rd level qualification (Science, Quality).
  • 5 years’ experience in the Pharmaceutical industry or a similar operating environment which includes experience in a Quality function.
  • Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation.
  • Quality Assurance SME knowledge, from both operational and educational experience, is required.
  • Knowledge and experience in interpreting current regulatory requirements and providing independent support to the site.
  • Demonstrated ability to work and succeed within teams as well as leading small project teams.
  • Proven track record of providing independent Quality support to the site.
    Advanced PC skills such as Excel, Word, PowerPoint.

To apply for this job email your details to patricia.arrue-elorza@tandempm.ie.