An exciting pharmaceutical organisation are currently recruiting for a Quality Compliance Specialist – Auditor to join their facility based in Hertfordshire on a permanent basis.
Reporting to the Head of Supplier and Customer Quality Assurance, the core function of the role will be to complete audits and assessments of the companies suppliers and service providers, write and review Technical & Quality Agreements, review and respond to customer & third-party audit and self-assessment questionnaires, as well as performing internal audits. To be considered for the role candidates must have a scientific degree and a minimum of five years relevant pharmaceutical experience within a GMP environment. The successful candidate will have good knowledge and understanding of EU GMP and US CFR regulations and guidelines, a qualification and/or experience in leading audits to GxP & ISO9001, experience in preparing Technical & Quality Agreements, as well as experience with internal, external, supplier and service provider auditing. Candidates with an understanding of current GMP issues affecting (sterile) pharmaceutical manufacturing and any experience in planning and taking part in regulatory inspections would be highly desirable.
The Quality Compliance Specialist – Auditor role is based in Hertfordshire and is commutable from North London, Luton, High Wycombe, Slough, Harlow and other locations across the South East of London.
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