Quality Assurance Specialist

6 days ago


Kilkenny, Kilkenny, Ireland Life Science Recruitment Full time

About Our Company

Life Science Recruitment specializes in placing top talent in pharmaceutical organizations.

We're seeking a highly skilled Quality Specialist to join our team at a Pharmaceutical organization based in Louth.

This is an exciting opportunity for individuals who are passionate about project work and making a tangible impact.

Duties

  • Carry out tasks related to the administration of event management systems including Review & Approval of Event and Deviations.
  • Manage batch records design and approval.
  • Coordinate site change control systems.
  • Approve and compile validation protocols and reports (analytical, cleaning, computer, process, equipment, etc.).
  • Review and approve SOPs/work instructions/forms from other departments on behalf of Quality Assurance.
  • Coordinate regulatory and customer GMP inspections of the site.

Required Skills and Qualifications

  • Bachelor's Degree in a scientific/technical discipline.
  • Experience in quality within the biological and/or pharmaceutical industry.
  • Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.


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