Senior Quality Assurance Specialist

1 week ago


Sligo, Sligo, Ireland Cpl Healthcare Full time
Job Description

We are seeking a highly skilled Senior Quality Assurance Specialist to support the QA department in our Sligo biopharmaceutical site.

About the Role
  • To act as a Qualified Person (QP) in the Batch Release group and certify medicinal products in accordance with regulatory requirements.
  • Assist in coordinating QA operational duties relating to product disposition, including deviation investigations and risk assessments.
  • Participate in ensuring product release procedures comply with current regulatory and company requirements.
Responsibilities
  1. Product Release: Certify medicinal products in accordance with regulatory requirements, ensuring compliance with product marketing authorization, Article 97 Veterinary Medicinal Directive, and EU GMP Annex 16.
  2. QA Coordination: Assist in coordinating QA operational duties, including batch disposition and related quality systems, ensuring timely and accurate completion of tasks.
  3. Investigations and Risk Assessments: Participate in investigating manufacturing deviations and changes, ensuring appropriate actions are implemented, and conducting risk assessments to mitigate potential issues.
  4. Quality Systems: Ensure product release procedures comply with current regulatory and company requirements, providing input into quality systems across the plant.
Requirements
  • Experience working within a pharmaceutical manufacturing environment in a Quality capacity (QA or QC).
  • QP qualification.
  • Experience of Quality systems, including deviation, out-of-specs, and risk management.


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