QA Specialist

1 week ago

Dublin, Dublin City, Ireland beBeeCompliance Full time €40,000 - €50,000
Key Responsibilities:
  • Material Documentation: Preparation, review, and approval of Material Qualification Documentation.
  • Raw Materials Disposition: QA disposition of raw materials, level 1 & level 2 consumables.
  • QA Procedures: Authoring, review, and approval of QA-related procedures.
  • Biologics Manufacture Review: QA review, assessment, and approval activities for Biologics Manufacture, including Change controls, Deviations/Investigations, Supplier Investigations, CAPAs, Supplier Change Notifications (SCN), TSE (Transmissible Spongiform Encephalopathy) Certificates, and other associated documentation.
  • Team Support: Be a core team member of the QA Compliance Materials Management team, engaging in other support activities as required.
  • Operational Excellence: Support establishment of Operational Excellence initiatives, such as 5S / Std Work / LSW / Kaizen / Problem Solving etc.
Requirements:
  • Education: BSc in Science or related discipline.
  • QA Experience: QA or related experience in a Biologics or Pharmaceutical environment.
  • cGMP Requirements: Clear understanding of cGMP requirements for manufacturing and/or systems compliance.
  • Material Qualification: Knowledge of material qualification & SAP would be a distinct advantage.
  • Communication Skills: Excellent communication and presentation skills are essential.
  • Time Management: Excellent time management and organisational skills along with a proven ability to multi-task.
  • Biopharma Behaviours: Employees are expected to display the Biopharma Behaviours, which enable them to be successful and perform at their highest level.

This is an exciting opportunity to join a company as a QA Compliance Materials Management professional. The role involves working on a large-scale project with cutting-edge technology and plenty of opportunities for learning and skill development.

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