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GCP Quality Auditor

  • Job type: Permanent
  • Location: Zürich
  • Salary: Negotiable
  • Job reference: 462513/001_1565882704
  • Sector: Quality Assurance, EPM Scientific
  • Date posted: 15/08/2019

Describe the job:

An innovative cancer therapy manufacturer is seeking an experienced Clinical Quality Assurance Auditor based in Switzerland. This company is at the leading edge of innovation and has developed a novel cancer therapy. Year-on-year growth is common for this company and they are looking for a new Clinical QA Auditor to help this continue.

Responsibilities:

    • Complete clinical trial QA audits on a frequent basis.

    • Maintain the high standards of the company by completing Clinical QA audits.

    • Ensure that clinical trials sponsored by the company are held accountable within the SOP's, regulations and with ISO 14155 requirements.

    • Retain audit results and implement actions based on the data effectively.

    • Work to improve audit procedures within clinical operations

    • Teach GCP, ISO 14155, MEDDEV, CFR, role of QA etc. to company staff

    • Be involved in a consultant role for the company's global Clinical QA Department in SOP prep and review, CAPA implementation etc.

Skills and Experience Required

    • Degree in Scientific/Technical discipline or Medicine

    • Experience in Clinical QA environment, preferably Medical Device if not Pharmaceutical

    • Experience in Regulatory Inspections and Auditing

    • Medical Device regulation knowledge (EN ISO 14155, ICH-GCP)

    • Fluent in English (mandatory), German is a bonus

    • Willingness to travel regularly (international/domestic)

How to apply

If you are interested in the Clinical QA Auditor position, apply online today or contact Blair Hoggan at +44 203 667 8377 for more information.

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