Quality Systems Specialist

2 weeks ago

Cork, Cork, Ireland beBeeQualityAssurance Full time €60,000 - €80,000

Job Overview:

We are seeking a Quality Assurance Specialist to support key quality activities within our Quality Monitoring team. The successful candidate will participate in inter-departmental and cross-functional teams, author site contributions to Annual Product Quality Reviews, and coordinate with global teams.

This role requires a solid understanding of quality assurance systems, current Good Manufacturing Practices (cGMPs), and standard QA procedures. The ideal candidate is proactive, detail-oriented, and able to exercise sound judgment within established protocols and guidelines.

Key Responsibilities:

  • Participate in inter-departmental and cross-functional teams.
  • Author site contributions to Annual Product Quality Reviews and coordinate with global teams.
  • Conduct counterfeit assessments related to product complaints.
  • Investigate customer complaints in a timely and thorough manner.
  • Collect and report on quality metrics.
  • Contribute to the authoring, reviewing, and approval of Standard Operating Procedures (SOPs) and other controlled documents.
  • Conduct QA walkthroughs to ensure site compliance with GMP requirements.
  • Work on routine assignments, recognizing deviations from standard practices.
  • Apply judgment within defined procedures to determine appropriate courses of action.

Required Qualifications and Experience:

  • Minimum of 2 years of relevant experience in a GMP-regulated environment.
  • Bachelor's degree in a scientific or related field.
  • Previous experience in the pharmaceutical industry, ideally within a QA function, is preferred.
  • Strong working knowledge of cGMPs and quality systems.
  • Familiarity with OPEX Lean tools and root cause analysis methodologies.
  • Demonstrated skill in audits, investigations, and technical report writing.
  • Proficiency in Microsoft Office applications.

Preferred Attributes:

  • Positive and proactive mindset.
  • Resilient and adaptable in dynamic environments.
  • Ability to engage with multiple stakeholders to meet objectives.
  • Curious, with a strong desire to learn and improve.
  • Operational excellence and systematic approach to prioritization.

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