Senior Product Quality Expert

2 weeks ago


Dublin, Dublin City, Ireland beBeeCompliance Full time €60,000 - €80,000
Product Quality Specialist

We are seeking a skilled Product Quality Specialist to join our team. This role plays a critical part in ensuring compliance and quality within the organization.

Main Responsibilities
  • Perform thorough reviews of third-party product documentation, including technical documents and prepare batches for certification.
  • Review and maintain Product Specification Files to ensure accuracy and compliance.
  • Manage batch review trackers, ensuring timely allocation of work across the QA team.
Quality Systems & Compliance
  • Raise and manage Events, Deviations, CAPAs, and Non-Conformance Reports in a timely manner, escalating to management as required.
  • Generate and report compliance metrics related to batch record review and preparation, ensuring continuous monitoring of QMS effectiveness.
  • Support the investigation and resolution of internal and external quality issues using risk management principles.
  • Author, review, and update SOPs, work instructions, and controlled documents.
Cross-Functional Collaboration
  • Partner with Project Managers, colleagues to drive timely resolution of batch-related issues and corrections.
  • Collaborate effectively across departments to ensure alignment and timely delivery of objectives.
Required Skills & Qualifications
  • Science Qualification, Degree and/or relevant experience is required.
  • 2 to 3 years of sterile experience in a manufacturing setting with good technical knowledge.
  • 7+ year's QA Experience in pharmaceutical or medical device is required.
Benefits

This role offers a challenging and rewarding environment with opportunities for growth and development.



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