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Senior Quality Assurance Specialist

2 weeks ago

Dublin, Dublin City, Ireland beBeeQuality Full time €40,000 - €55,000

Job Summary

As a Quality Assurance Specialist, you will play a vital role in ensuring the quality of our products and services. You will be responsible for enforcing relevant standards and procedures, and coordinating quality assurance activities to ensure compliance with regulatory requirements.

About Us

We are a rapidly growing company that operates in a complex global regulatory environment. Our business involves delivering vital medicines securely on time and wherever they are needed in the world.

Key Responsibilities

  1. To follow, promote and enforce relevant SOPs, Job Aids, and Company policies and procedures.
  2. To assist in ensuring that the appropriate standards of GMP and GDP are maintained.
  3. Origination, review, approval, maintenance and archiving of quality documentation. This includes but is not limited to policies, SOPs etc.
  4. To assist in the organization and delivery of appropriate training in this area.
  5. Coordinate Quality Assurance raw data to ensure compliance with regulatory expectations.
  6. Collation of raw data to support monthly quality arrangement system indicator (QMS) reporting.
  7. As required contribute to the delivery of QA projects.
  8. Deal with QA enquiries promptly with due diligence.
  9. Ensure all quality critical documents are appropriately drawn up, maintained, reviewed filed and archived to ensure compliance with regulatory and customer expectations. Additionally, providing reports to the group head of Quality, Quality Manager and other nominated parties to show status and progress.
  10. Coordinate QA raw data including Change Controls, CAPA Management, Deviation Investigation, Temperature Excursion investigations, Product Discrepancy investigations, Product Recalls, product Quality Complaints.
  11. QA Inbox Management.
  12. Support the self-Inspection process.
  13. Support the Supplier Approvals Process.