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QA Specialist

Quality & Laboratory
Cork
Siobhán Lane
Permanent
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Job Reference: JO-2106-65841_1623254194

Summary:

The successful candidate will be required to perform QA review of production records & associated documents and QA review & approval of procedures and GMP deviations.

Responsibilities:

  • Review and approval of change controls, observations/ deviations, failure investigations, suspect analytical results, product quality complaints, stability studies and reports associated with the manufactured batches.
  • Review and approval of GMP documents associated with qualification and validation including IQ/OQ/PQ & validation documents for facility and Annual Product Reviews.
  • Re-identification, re-evaluation & disposition of raw materials, intermediates and packaging components used in the manufacture of relevant pharmaceutical products where necessary.
  • Batch disposition, including approval of batch records, for API and Intermediate batches & approval of CoA's.

Requirements:

  • BSc, MSc, or PhD in Chemistry, Engineering or related discipline, with minimum 3 years relevant experience.
  • Excellent attention to detail.
  • Demonstrates ability in critical thinking, data analysis, problem solving and experience in root cause analysis.

Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

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Talent Consultant:
Siobhán Lane
Siobhán Lane
Talent Consultant
Quality & Laboratory
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