Auditor (Contract) Position

1 day ago


Marlow, United Kingdom Kyowa Kirin International Full time
Job Title: Auditor (Contract)

We are seeking a highly skilled Auditor to join our team at Kyowa Kirin International. As a key member of our Quality Assurance department, you will be responsible for implementing, executing, and maintaining our EMEA GxP Quality Management Systems.

Key Responsibilities:
  1. Develop and maintain an adequate audit plan for global, regional, and local trials, systems, and compliance processes.
  2. Manage qualified service providers for GQA, including contract auditors.
  3. Perform annual risk assessments and ensure continuous improvement of the PV Quality System.
  4. Collaborate with Functional Area Heads, Global and Regional Quality Leads, and other functions to foster a continuous improvement mentality within Kyowa Kirin.
  5. Ensure the establishment and maintenance of required Quality Documentation.
  6. Identify process gaps and deficiencies in the Quality System and collaborate with other Functional Areas and partners for resolution.
  7. Manage deviations reported by Functional Areas and support them with resolution.
  8. Support inspections and health authority inspection management.
  9. Support the preparation for GVP inspections and responses to Regulatory Authorities.
Requirements:
  1. Degree in natural science or equivalent number of years' experience.
  2. Qualified auditor with experience in Quality Management Auditing for Pharmacovigilance.
  3. Clinical/industry/Regulatory Authority or otherwise relevant experience.
  4. Expert knowledge/experience in relevant regulations and guidance documents, such as Pharmacovigilance, Clinical Development, Medical Device, IMP management, and Regulatory Affairs.


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