AbbVie Quality Specialist (Contract) in Ballytivnan, Ireland

Quality Specialist (Contract)

New

Ireland, Connaught, Ballytivnan

Quality Assurance

Requisition #1803618

We’re driven by the impact we can have on people’s health around the world, and this gives focus to our work every day.We are currently sourcing a Quality Specialist to join our team in Ballytivnan, Sligo on a contract basis.

Key Responsibilities Include:

  • Coordinating appropriate assigned elements of the Quality System, ensuring full compliance by all relevant plant personnel with its requirements.

  • Management of Environmental Monitoring System.

  • Management of compliance to on-site cleaning program.

  • Management of sterilization compliance.

  • Data, trend analysis & reporting on an adhoc and routine basis.

  • Ensure all plant personnel are fully aware of quality requirements (where relevant) by providing the necessary training.

  • Ensure implementation and compliance with relevant Regulatory requirements.

  • Ensure Quality System documentation is thorough, complete, and compliant. Ensure compliance to training requirements is maintained.

  • Participation in Continuous Improvement programs to implement improvements in the quality, safety, environmental and production systems at the site.

  • Other Quality related tasks as required

Qualifications:

  • Degree in Science, Engineering or Quality.

  • Green Belt qualified or demonstrated knowledge of statistics in an industrial environment is desirable.

Technical/Business Knowledge:

  • 2 year plus experience in the day-to-day operation of the quality system in a highly regulated Combination Product/Device manufacturing environment or Pharmaceutical manufacturing environment.

  • Minimum 2 years working knowledge of quality systems regulations (ISO13485/ISO9001; 21 CFR Part 820) or individual elements within the regulations such as; process validation, design controls, CAPA, auditing, etc., is desirable.