Senior Quality Assurance Expert

2 weeks ago

Cork, Cork, Ireland beBeequalification Full time €93,292 - €103,466
Job Title: Senior Qualification Specialist

We are seeking a highly skilled Senior Qualification Specialist to join our team. In this role, you will be responsible for defining and implementing procedures and processes to ensure our facilities, equipment, and supporting systems meet the highest standards of quality.

The ideal candidate will have a strong background in Quality and Qualification and Validation with at least 5-8 years of relevant experience in an industry environment. Advanced knowledge of Quality, Engineering, cGMP, ICH, and ISO guidelines is essential, as well as Risk Assessment applied to Qualification and Validation and LEAN 6-Sigma.

  • Develops and implements quality management systems to ensure compliance with regulatory requirements
  • Works collaboratively with colleagues to design test strategies and methodologies for qualification and validation application
  • Ensures cGMP compliance in activities related to Qualification and Validation of systems/equipment, utilities, and facilities throughout their lifecycle

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