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Sean McCarthy
Life Science

+3530212339371
[email protected]
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Details

Quality Assurance Specialist


Reference:SMC5689 Location: Tipperary
Qualification:DegreeExperience:See description
Job Type:PermanentSalary: Not Disclosed
May be suitable for: QA Executive

We’re currently recruiting for an exciting opportunity with a Pharmaceutical organization based in Tipperary. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Duties

  • 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
  • Liaise with customers for products which are contract manufactured
  • Review Batch Documentation
  • Any other projects relating to quality standards/requirements as assigned by Quality Assurance Manager/Quality Compliance Manager.
  • Internal comment investigation
  • 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.

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

If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or [email protected] for further information.