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Quality Assurance Officer

Ref: 9221739

  • €30,000 - €32,000
  • 17 Sep 2020
  • Tipperary
  • Perm

A diverse Pharmaceutical manufacturing site in Tipperary requires a Quality Assurance professional to cover a 6 month contract. The role is primarily focused on handling Customer Complaints and associated investigations. About the Job:
  • Originating, Approving and Issuing Production Documentation (Manufacturing & Packaging).
  • Originating, Approving and Issuing Standard Operating Procedures (SOP's), in compliance with cGMP requirements.
  • 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.
  • cGMP training.
  • Internal and external auditing.
  • Investigating customer complaints
  • Proofing and approval of artwork.
  • Liaise with customers for products which are contract manufactured.
  • Review Batch Documentation.
  • Internal comment investigation.
  • Change control, vendor certification and approval of suppliers, raw material review.
  • Temperature monitoring.
  • CAPA reports.
  • About you:
  • Third Level Scientific qualification preferably to degree level or appropriate experience.
  • 1-2 years in a Quality role in a regulated manufacturing environment.
  • For more on the role call Nigel on 087 3618142 or send your CV for consideration.