Auditors performing audits have a broad professional experience within the Chemical and Pharmaceutical fields. Besides, they have carried out numerous audits to pharmaceutical industry suppliers. All of them have been qualified by means of the AFA auditor qualification program as described in the Intercompany Protocol as well as in the specific SOP, which guarantees their technical competence and demonstrated experience. The auditors should have the following profile:
- Advanced University Degree in Chemistry, Pharmacy, Chemical Engineering or similar.
- Good knowledge of the EU regulations that apply to the Research & Development, Manufacturing and Distribution of Pharmaceutical products and their raw materials.
- Knowledge of the procedures needed for the marketing authorisation of Pharmaceutical products.
- A minimum of 2 years’ experience working in an organization regulated by the GxP principles, holding a position of certain responsibility.
- Experience in the processes of pharmaceutical manufacturing and control, chemical synthesis and the validation of these processes or methods.
- Experience in the design or qualification of facilities for GxP purposes.
- Experience in Quality Control organization and technology.
- Experience in the computer systems commonly used in the pharmaceutical industry and chemical environment and its validation.
- Ability to maintain the objectivity and consistency approach during the audits.
- Communication skills and ability to create an environment that facilitates communication.
- Analytical mind and tenacity.
- Maturity and open-mind.
- Personal integrity.
- Ability for conveying ideas in a clear and concise manner.