Lab Compliance Professional

2 weeks ago

Sligo, Sligo, Ireland beBeeCompliance Full time €60,000 - €90,000
Lab Compliance Specialist

We are seeking a highly skilled professional to fill the role of Lab Compliance Specialist. The successful candidate will be responsible for leading and managing project-related activities in the QC department, ensuring compliance with regulatory requirements and maintaining high standards of quality control.

Key Responsibilities:
  • Lead and manage all project-related activities in the QC department, ensuring timely completion and meeting regulatory requirements.
  • Oversee the introduction of new analytical techniques, focusing on automation and paperless laboratory systems, to improve efficiency and productivity.
  • Manage the implementation of the Lab of the Future initiative in the QC department, driving innovation and excellence in laboratory practices.
  • Coordinate and oversee laboratory expansion projects, ensuring seamless integration and minimal disruption to operations.
  • Manage and oversee compendial reviews, documentation control for QC, maintenance and calibration of analytical instrumentation, analytical work orders on maximo and retain management, ensuring accuracy and reliability of results.
  • Manage purchasing and budget control, including vendor managed inventory, laboratory cleaning services and capital requirements for QC, optimizing resources and minimizing costs.
  • Manage and ensure delivery of training curricula for QC via laboratory trainer role, empowering employees with the necessary skills and knowledge to excel in their roles.
  • Lead operational excellence in QC, delivering on various initiatives including reduced testing program for QC, improving efficiency and reducing waste.
  • Liaise with PDS&T to ensure execution of reference standard interval testing program, ensuring compliance with regulatory requirements and maintaining high standards of quality control.
  • Lead inspection readiness in QC, preparing the team for audits and inspections, and addressing any findings or recommendations.
  • Participate in internal and external audits, addressing audit findings and implementing corrective actions to maintain compliance with regulatory requirements.
  • Ensure compliance with data integrity policies and regulatory requirements, maintaining accurate and reliable records and reports.
  • Liaise with cross-functional teams to facilitate project goals and timelines, ensuring effective communication and collaboration across departments.
  • Present project updates and technical data to stakeholders effectively, communicating complex information in a clear and concise manner.

Requirements:

  • Bachelor's/Master's degree in Chemistry or a related field.
  • Experience working in API and OSD QC laboratories, with a strong understanding of regulatory requirements and laboratory practices.
  • Minimum 4 years of experience in people management within a QC lab setting, with a proven track record of leadership and team development.
  • Strong project management, presentation, and communication skills, with the ability to communicate complex information in a clear and concise manner.
  • Innovative thinking, with a commitment to advancing laboratory practices and compliance, driving continuous improvement and excellence in laboratory operations.

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