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Quality Assurance Officers

  • Location: Tipperary, Tipperary, Munster, Ireland
  • Job Type:Permanent

Multiple Quality Assurance Officers required for a leading healthcare organisation in the South East.

Overview of Main Responsibilities (full job description available on request):

  • Originating, Approving, and Issuing Production Documentation (Manufacturing & Packaging).

  • Originating, Approving and Issuing Standard Operating Procedures (SOP's), in compliance with cGMP requirements .

  • Reviewing SOP's, as per review schedule.

  • Issuing Stability Documentation, approval of testing protocols, review of stability reports.

  • Reviewing Validation protocols & validation reports (including process validation, cleaning validation, and equipment validation protocols and reports).

  • Reviewing Product Development Documents.

  • Internal and external auditing.

  • Investigating and review of deviations and out of specification results.

  • Investigating customer complaints.

  • Proofing and approval of artwork.

  • Review Batch Documentation.

  • Change control , vendor certification and approval of suppliers, raw material review.

  • Temperature monitoring.

  • CAPA reports.

  • APR’s.

  • FPS approval.

  • Support elemental impurities, excipient risk assessments, PQR reporting, and production support.

What the ideal candidate looks like:

  • Educated Degree level – Chemistry, Pharmacy, or Biological Science. with experience within the pharmaceutical industry, preferably within QC or QA or appropriate experience

  • Excellent organisational and time-management skills.

  • Ability to leverage/collaborate effectively with internal and external stakeholders.

What you will get in return:

  • Competitive Salary (depending on experience).

For a confidential discussion and more information on the role, please contact Aisling Lane.

aisling.lane@collinsmcnicholas.ie

(021) 4320675