Quality Assurance Professional

2 weeks ago

Dunboyne, Meath, Ireland beBeeInvestigations Full time €55,000 - €75,000

Our organization seeks a highly skilled Quality Investigations Specialist to join our team. This individual will be responsible for drafting, reviewing, and finalizing quality notifications, ensuring clarity, accuracy, and compliance with regulatory requirements.

The ideal candidate will have a strong background in technical writing, quality management systems, and GMP environments. They will work independently and within cross-functional teams to ensure effective communication and follow-up of quality-related metrics.

Key responsibilities include:

  • Drafting, reviewing, and finalizing quality notifications, ensuring clarity, accuracy, and compliance with regulatory requirements.
  • Initiating and maintaining quality-related metrics related to quality notifications, ensuring effective communication and follow-up of the same.
  • Solely managing the authoring of incident reports, documenting quality issues, and ensuring timely submission for review and approval.
  • Leading the authoring of comprehensive investigation reports, detailing findings, root cause analyses, and corrective actions.
  • Navigating the approval process for all authored documents, collaborating with cross-functional teams to ensure timely reviews and compliance with quality management systems.
  • Participating in quality risk assessments as needed, providing insights and documentation to support the evaluation of quality risks.

Requirements for this position include:

  • A bachelor's degree in Biotechnology, Chemistry, Biology, Pharmacy, or Process Engineering.
  • At least two years of experience in the biotech industry (bulk manufacturing of pharmaceutical or biological components). The level of this position will scale with the experience level of the candidate.
  • Strong technical writing capability and previous experience authoring reports and investigations in a GMP environment.
  • Competent in analyzing complex situations and showing practical problem-solving capabilities.
  • Ability to work independently and within cross-functional teams.

Preferred skills for this role include:

  • Experience leading and facilitating Root Cause Analysis and Quality Risk Assessment sessions.
  • Experience supporting Regulatory Inspections and Site Internal Audits.
  • Understanding of Upstream and Downstream Unit Operations for mAb manufacturing.

This role reports directly to the Drug Substance Support Operations Associate Director and is located at our facility in Dunboyne, Ireland.

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