Quality Assurance Specialist

2 days ago

Dublin, Dublin City, Ireland beBeeRiskManagement Full time €80,000 - €120,000
Job Title: Risk Surveillance Lead

This role involves driving the adoption of quality management practices at the trial level and overseeing their implementation and continuous improvement.

Main Responsibilities:
  • Facilitate trial protocol risk assessments across multiple domains, defining tolerance limits and evaluating risks based on likelihood, detectability, and impact.
  • Draft and maintain study-specific documentation of risk management activities, including the Integrated Quality Risk Management Plan (IQRMP).
  • Partner with system configuration teams to ensure indicators, tolerance limits, and analytics are programmed according to operational requirements.
  • Conduct central surveillance of aggregate data at the study and program levels, leveraging available analytics to identify emerging risks or issues.
  • Facilitate risk review meetings with team members to communicate findings and develop mitigation strategies.
  • Support internal and external audits and inspections.
Required Skills and Qualifications:

The ideal candidate will have a Bachelor's Degree in a health-related or life sciences field, along with minimum 4 years of experience in the pharmaceutical or CRO industry. They should also possess strong knowledge of drug development and clinical trial execution, as well as regulatory standards such as 21 CFR Part 11, ICH E6, and ICH E8 (GCP).

  1. Robust understanding of drug development and clinical trial execution.
  2. Knowledge of regulatory standards.
  3. Experience with risk management and sponsor audits.
  4. Strong analytical skills, including data analysis and problem-solving.
  5. Effective communication and leadership skills.
About Us:

We are committed to fostering a culture of continuous improvement and knowledge sharing. If you are a motivated individual looking for a challenging role, we encourage you to apply.

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