Senior Quality Assurance Specialist

2 weeks ago

Cork, Cork, Ireland beBeeQuality Full time €59,000 - €86,000
QA Specialist Job Description

We are seeking a highly skilled QA Specialist to join our Quality Assurance Department.

This role requires a solid understanding of quality assurance systems, current Good Manufacturing Practices (cGMPs), and standard QA procedures.

The ideal candidate will have a proactive approach, be 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.

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 (FDA / EMA standards).
  • Familiarity with OPEX Lean tools and root cause analysis methodologies.

Preferred Personal Attributes:

  • Positive and proactive mindset.
  • Resilient and adaptable in dynamic environments.
  • Ability to engage with multiple stakeholders to meet objectives.

Core Values Expected:

  • Integrity – Always doing the right thing
  • Teamwork – Collaborating effectively and in good faith
  • Excellence – Committed to high performance and quality standards
  • Accountability – Taking ownership of responsibilities and outcomes
  • Inclusion – Embracing diversity and fostering a collaborative environment

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