Third-Party Product Quality Assurance Specialist

2 weeks ago


The Municipal District of Dundalk, Ireland beBeeQualityAssurance Full time €40,000 - €55,000

As a Quality Assurance Specialist, you will be responsible for ensuring the quality of products manufactured by third-party companies.

This role offers an exciting opportunity to work in a dynamic environment with multiple stakeholders across various departments.

  • Compile and review batch documents prior to QP review.
  • Collaborate with responsible sites to complete corrections and prepare COC for QP.
  • Perform reviews of batches manufactured/packed at PCI or in third-party companies, identifying deviations and initiating corrective actions as needed.
  • Request and review certificates of analysis/conformance for API/drug substance, bulk product, packaging records from customers/suppliers against approved filing/dossier.
  • C Coordinate product supply chain flows and participate in customer meetings to discuss quality documentation.
  • Develop SOPs or work instructions and maintain batch documents and retain samples in archive rooms.
  • Maintain safe work practices and report any near misses to the EHS Department immediately.

The ideal candidate will possess a degree and/or relevant experience, GMP knowledge, steriles expertise, strong communication skills, problem-solving ability, and capability to set clear goals and ensure progress to completion meeting predefined targets.

Minimum 2 years' experience working in Quality Assurance is required, along with a proven track record of delivering results through management/leadership of others.



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