Location: Fannin Limited, Ballybrit Upper, Galway, Ireland

Department: Quality Control

Reporting to:  Site Quality Manager      

Principal Duties and Responsibilities:

Provide leadership and support in coordinating and enabling Quality Control activities, while ensuring compliance with quality standards and accreditation under ISO17025 through activities such as:

• • Lead the Quality Management Systems for the laboratory ensuring the requirements of ISO 17025 are implemented, effective and complied with.
  • Schedule, co-ordinate and supervise all testing within the QC laboratory ensuring that all testing is carried out in a timely fashion to meet company objectives and relevant KPIs.
  • Supervise and develop the core QC Lab team by mentoring, training, and supporting personnel development plans, including allocate daily tasks for all QC lab personnel, staff issues, allocation of holidays, delegation of extended working hours when required, and in conjunction with company management policy and requirements.
  • Represent the QC laboratory with support of the Quality department in regulatory and customer audits and coordinate the timely close out of NC actions / recommendations identified from relevant audits.
• Develop, maintain, and ensure implementation of in-house documents e.g. Standard Operating Procedures, Validation Protocols, Risk Assessments, technical files, etc.
  • Maintain GLP compliance in the QC laboratory.

Execution:

• • Oversee QC SOP’s updates, change controls, deviations, CAPA’s and Laboratory investigations.
• Review and ensure application of relevant standards relating to product testing and laboratory compliance.
  • Perform product/batch release following review and verification of test results to ensure product/batch compliance.
• Ensure publication of batch certs of analysis on the website when testing is complete, and results confirmed compliant.
• Co-ordinate and supervise laboratory investigations to ensure they are captured, documented, and actioned upon within a timely manner.
  • Ensure the implementation of appropriate corrective and preventative actions as deemed necessary following Quality team review.
• Review and trend lab generated data to ensure continual improvement.
• Report on trends monthly in the monthly report when required.
• Support the Quality Department with preparation for Laboratory Management Review and Quality Control meetings.
• Mediate between the testing personnel and all other departments.
• Perform and facilitate/lead internal audits, regulatory audits, supplier audits, and customer audits.
• Support management and completion of site audit schedule.
• Lead communication with LIP customers regarding technical queries.
• Support raw material and supplier performance reviews.
• Coordinate equipment calibration, maintenance and qualification to the predetermined schedule.
  • Maintain lab consumables to ensure continuous supply and no impact on testing.
• Ensure competency and EQA testing-pH and WASP is performed.

Development:

• Arrange and support training, continual improvement and supervision of test personnel.
• Provide technical support to QA and Production functions and Fannin Ltd customers when requested.
• Advise, facilitate, and implement systems to ensure continuous improvement of processes and services.

Planning:

• Prepare and propose plans both long and short term for your area of responsibility in line with the companies defined strategy and agreed financial targets.
• Ensure test method and equipment validations are completed on time.
• Provide cover for other team members as required.

Requirements:

• Relevant Third Level qualification.
• Working knowledge of ISO 17025.
• Experience in GDocP and ISO environments.
• Experience in lead and/or supervisory roles.
• Track Record in project management.
• Flexibility to travel and ability to audit effectively.

Desirable Qualifications:

• Working knowledge of IVDD 98/79/EC and/or IVDR (EU) 2017/746.
• Auditor Certified (e.g. ISO 17025, ISO 9001).
• Knowledge of Irish EHS and Environmental Legislation and regulations.
• QMS software systems experience.
• Validation Experience.

Desired Characteristics:

• Pro-active.
• Flexible and adaptable to changing environment.
• Ability to interface effectively with all levels within the company as well as organizations outside Fannin (regulatory agencies).
• Proven problem solving and trouble shooting skills.
• Strong oral and written communication skills.
• Strong interpersonal and leadership skills.
• Ability to plan and prioritise work to meet commitments aligned with organisational goals.

Although the above is a description of the requirements of the role, as stated in your contract of employment, you may be required to carry out other reasonable duties as the Company may require from time to time.

Please note that all DCC Vital staff work within quality management systems and that all of the above will apply to the product portfolio.

DCC VITAL IS AN EQUAL OPPORTUNITY EMPLOYER