AbbVie Quality Specialist (Contract) in Ballytivnan, Ireland
Quality Specialist (Contract)
Ireland, Connaught, Ballytivnan
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
Degree in Science, Engineering or Quality.
Green Belt qualified or demonstrated knowledge of statistics in an industrial environment is desirable.
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.