AUDITORS

AUDITORS PROFILE

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, which guarantees their technical competence and demonstrated experience.

1.a Minimum required Academic Education and knowledge:

The minimum Academic Education to be able to become an AFA qualified auditor is: BSc Honours Degree in Pharmacy, Chemicals, Engineering or similar.

Besides, a good knowledge of GxP (GMP, GLP, GCP) as well as the applicable regulations and guidelines for Research & Development (R&D), Manufacturing and Distribution of Pharmaceutical products, is required.

Knowledge of the procedures needed for the marketing authorisation of Pharmaceutical products.

1.b Minimum required professional experience:

A minimum of 2-year experience working in an organization regulated by the GxP principles, holding an upper management position is required.

Audit execution experience within the same scope for which the future auditor is being qualified for.

Pharmaceutical manufacturing and control, chemical synthesis and the validation of these methods or processes proven experience.

Design and qualification of facilities for GxP purposes experience.

Quality Control management and technology experience.

Computer Systems experience using applications commonly used in the pharmaceutical and chemical environment together with validation experience on these systems.

1.c Personal Skills:

Ability to maintain the objectivity and uniformity criteria during audits.

Communication skills and ability for creating an open atmosphere to ease the exchange of information.

analytical mind and perseverance.

Mature and open-minded.

Personal Integrity.

Ability for conveying ideas in a clear and concise manner.