QA Specialist

  • Cork
  • Contract
  • JO-1707-62697_1500904072

Summary

Responsibilities

  • Review all documentation associated with batch release to ensure GMP compliance.
  • Verify the labelling of the raw material, packaging components, bulk and finished product.
  • Ensure the follow-up of the necessary corrective actions & preventative actions implemented in consequence of a quality failure
  • Perform investigations, and ensuring a follow-up, following discrepancy, failures and external complaints.
  • Participate in KPI meetings to assist the batch release process.
  • Review the GMP documentation eg, SOPs, reports, methods, specifications, validation protocols, quality contracts etc.
  • Perform the Annual Product Review (data collection, graphic analysis…)
  • Writing and reviewing QA department procedures and reports eg. protocols, SOPs, environmental reports etc.



Requirements

  • BSc in Science or related area
  • Minimum 3 years' pharmaceutical experience in a regulated environment would be preferable.
  • Knowledge of GMP. Good organisation skills and time management. Analytical approach to problem solving. Word, Excel
  • Teamwork, flexibility, information gathering, execution, problem analysis & initiative

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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