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Quality Specialist

4 weeks ago

Cork, Cork, Ireland Recruitment by Aphex Group Full time

Purpose

The Specialist is a member of a team within Quality and is involved in supporting the GMP Quality Assurance activities.

Responsibilities

  1. Review and approve production and analytical documentation accompanying the release of drug substance, drug product and packaged finished goods to ensure conformance to appropriate SOPs, GMP and regulatory requirements, including supporting QP certification.
  2. Perform and review complaints and deviation investigations, change controls and CAPA's.
  3. Create and maintain assigned SOPs.
  4. Compile data for reports and presentations, provide data interpretation, and draw conclusions.
  5. Complete audits to ensure compliance to SOPs, GMPs and applicable regulations.
  6. Support product recalls and stock recoveries as appropriate.
  7. Actively communicate and collaborate with functional areas to develop a strong working relationship and understanding of roles and responsibilities. Utilize this network to help resolve comments and issues that arise during audit and review.
  8. Identify compliance gaps and make recommendations for continuous improvement.
  9. Assist in the induction process for new starters and training of other staff.
  10. Generally, follow standard procedures and consult with manager/supervisor on exceptions.
  11. Carry out all assignments to the standards of compliance, efficiency, innovation, accuracy, and safety in accordance with Company and regulatory requirements.
  12. Keep abreast of cGMP requirements as described in applicable worldwide regulations.
  13. Represent the department on cross-functional teams.
  14. Additional activities as assigned by the manager/supervisor.

Qualifications

The Specialist is required to possess a degree in a Science or Engineering discipline plus considerable industrial experience.

Skills:
Quality, GMP, SOPs, CAPA, Deviations

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