Qualified Person (12 Month Contract) Cork, Jobs, 497

Qualified Person (12 Month Contract) - Cork

Contract / Temp
€80 - €100 Per Hour
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Our client, a Multinational Biopharmaceutical company, are currently seeking an experienced and proactive Qualified Person to support their operation in their Cork facility.

This is a 12-month contract role based onsite in Cork.




  • Complies with the responsibilities of Qualified Person (QP) stated in directives issued by EC to Certify Batch Releases for sale or supply in compliance with regulations.
  • Responsible for change control, non-conformities, and CAPAs.
  • Participate in Internal & External Audits.
  • Own, review, and approve SOP's and other GDP/cGMP documentation and records.
  • Validate the primary manufacturing and testing processes.
  • Provide QP support to quality related issues, as the need arises.
  • Participate in cross-functional teams as Quality / QP representative.
  • When required, serve as a lead/coordinator of investigations and CAPA recommendations related to manufactured products.
  • Works with Research and Development during new product start-ups and establishes key checkpoints for new products and processes.
  • Participate in investigations and risk assessments related to manufacturing deviations and changes and ensuring appropriate actions are implemented.


Professional Experience & Qualifications


  • Required Degree or Certification: BS desirable.
  • 2 years + relevant experience in Pharmaceutical, Manufacturing, GMP Environment.
  • Knowledge of current Good Manufacturing Practices (GMPs).
  • Excellent Communication & Interpersonal skills
  • Exemplary attendance and time-keeping record
  • Excellent Computer Skills



Contract – 12 Months. Normalised office hours. Site Based.



Circa €80 - €100 Per Hour -  Generous and competitive compensation is available to the successful candidate.


For a confidential discussion on this or any other current opportunities please contact Mark Farrell   mark@logiskills.ie