Lead Quality Assurance Specialist

2 weeks ago

Shannon, Ireland beBeeData Full time €80,000 - €100,000
Lead Quality Assurance for Research Excellence

We are seeking a highly skilled Associate Director to play a pivotal role in ensuring the highest standards of quality and compliance in our research initiatives.

This key position involves overseeing the validation and adherence to regulatory requirements for digital systems supporting production, lab, and storage functions. You will lead efforts in data governance, system validation, and inspection readiness while fostering a culture of continuous improvement and compliance.

Key Responsibilities:
  • Quality Standards Implementation: Develop and maintain quality standards for electronic systems and data management.
  • Validation and Compliance: Oversee the validation and compliance of computerized systems, including manufacturing and laboratory platforms.
  • Inspection Readiness: Conduct inspections and assessments to ensure adherence to regulatory requirements.
  • System Change Controls: Manage system change controls, deviations, and corrective actions.
  • Data Integrity Frameworks: Develop frameworks to ensure data quality and integrity across all processes.
  • System Oversight: Provide oversight for systems such as MES, DeltaV, LIMS, ELN, and SAP.
  • Automation Initiatives: Support automation initiatives and system integration projects.
  • Regulatory Preparedness: Prepare for and participate in regulatory inspections and audits.
  • Training and Mentorship: Train and mentor team members on data integrity and compliance practices.

Required Skills and Qualifications:

  • A background in science, engineering, computer science, or a related field.
  • Knowledge of regulatory standards (e.g., FDA, EMA, GAMP 5) and data integrity principles.
  • Experience with laboratory systems (e.g., LIMS, CDS, ELN) and enterprise platforms (e.g., SAP, MES).
  • Strong leadership, communication, and decision-making skills.
  • Familiarity with system validation processes, including risk-based approaches.

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