Executive Team Leader

1 week ago

Shannon, Ireland beBeeOperations Full time €90,000 - €120,000
Job Title:

Ambitious Operations Director Wanted

Description:

We are seeking a highly skilled and experienced Operations Director to lead our team. The successful candidate will be responsible for ensuring the standards, regulatory compliance, and reliability of digital systems supporting production, lab, and storage functions.

Key Responsibilities:
  • Develop and maintain quality standards for electronic systems and data management.
  • Oversee validation and compliance of computerized systems, including manufacturing and laboratory platforms.
  • Conduct inspections and assessments to ensure adherence to regulatory requirements.
  • Manage system change controls, deviations, and corrective actions.
  • Develop frameworks to ensure data quality and integrity across all processes.
  • Provide oversight for systems such as MES, DeltaV, LIMS, ELN, and SAP.
  • Support automation initiatives and system integration projects.
  • Prepare for and participate in regulatory inspections and audits.
  • Train and mentor team members on data integrity and compliance practices.
Requirements:
  • Bachelor's degree in science, engineering, computer science, or a related field.
  • Demonstrated 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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