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QA Specialist

3 weeks ago

Dublin, Dublin City, Ireland beBeeQuality Full time €45,000 - €70,000
Job Description

We are currently recruiting for a Quality Assurance Specialist to join our team in Carlow. This is an excellent opportunity for anyone looking to join a leading multinational who are one of the best at what they do.

Key Responsibilities:
  • Review and approval of all manufacturing batch documentation including electronic batch records, real-time reports, and master data using site systems.
  • Review and approval of SOPs, cleaning verification/validation data and other documents as necessary for the IPT department.
  • Drive effective writing/revising/rolling out of accurate operational procedures, training materials and maintenance procedures for various quality-related systems; ensure all work is subsequently carried out in line with same.
  • Support the development and implementation of improved quality reporting measures.
  • Liaise with the Quality Specialists/QP/QA Lead to resolve queries relating to batch manufacturing process.
  • Verification of the effective implementation of key GMP programs.
  • Effectiveness of Preventative Actions.
  • Provide training in all aspects of Quality Management Systems and GMP.
  • Ensure all work is carried out in line with SOPs, training or other quality systems such as change controls where applicable.
  • Aid the effective implementation of the Quality Management System and facilitate the continuous improvement of same, ensuring the Quality Management Systems are accurate and complete; review on a continuous basis. Be an advocate of continuous improvement in the Quality Management Systems.
Requirements

To be successful in this role, you will need:

  • Third Level Degree qualified in a Science/Technical or related discipline.
  • Relevant experience in a quality role, ideally in a pharmaceutical manufacturing environment.
  • Knowledge of US and European cGMP guidelines, and other international regulatory requirements, as applicable to the site.
  • GMP Audit experience in the pharmaceutical industry.

If you have the skills and qualifications required for this role, please contact us for further information.