Operational Excellence Specialist

3 days ago

Limerick, Limerick, Ireland beBeeQuality Full time €90,000 - €120,000
Job Title: Operational Excellence Specialist

The successful candidate will oversee the support operations and lead teams to ensure equipment qualification and maintenance programs align with regulatory requirements, fostering a culture of excellence within the organization.

Main Responsibilities:
  • Maintain oversight of equipment lifecycle activities, including procurement, installation, qualification, maintenance, and decommissioning to optimize performance and efficiency.
  • Provide direction to staff supporting equipment, ensuring alignment with regulatory agencies' requirements and promoting compliance across the board.
  • Collaborate with cross-functional teams to establish internal requirements for equipment and drive QC equipment validation/qualification efforts, resulting in streamlined processes and enhanced quality.
  • Manage oversight of preventive and corrective maintenance monitoring program, as well as external laboratories activities and performance monitoring of testing laboratories.
  • Supervise issuance and approval of Quality agreements and SLAs with contract labs, ensuring global procedures reflect current contract lab utilization and minimizing risks.
  • Identify and report issues at contract laboratories to leadership and source GMP activities relating to new contract lab introduction, upholding industry standards.
Requirements:
  • Possess strong communication and interpersonal skills to effectively collaborate with multiple stakeholders.
  • Demonstrate logical troubleshooting and problem-solving skills to address complex issues and provide timely solutions.
  • Have a detailed understanding of equipment qualification and maintenance activities and industry compliance norms to ensure seamless operations.
  • Be able to communicate effectively with partners and work in a fast-paced environment, prioritizing tasks and meeting deadlines.
  • Demonstrate a collaborative and team-orientated approach to achieve shared goals and objectives.
Education and Experience:

A bachelor's degree in chemistry, biology, or a related field is required, along with 8+ years of proven experience preferably in the pharmaceutical or biotechnology industry, and previous supervisory or leadership experience.

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