MAKING COMPLIANCE ACHIEVABLE
Practical and accessible quality solutions for pharmaceutical organizations
About Me, José
I started working as an independent consultant under the name Allione in 2008. I have over 30 years’ experience in the pharmaceutical industry, including more than 25 years in quality assurance. As a trained bioprocess technologist, I initially supported the production of biologicals for human and veterinary applications. As a consultant, I began delving deeper into validation, QA systems and compliance. I have seen a lot and have gained valuable experience. All these experiences inform my current work as a QP and QA specialist. It is important to me that the work I deliver to my clients is sustainable. By this, I mean that it aligns with the organization’s culture and is straightforward to implement.
As a quality expert, I am happy to promote the GMP/GDP philosophy through training courses and one-to-one support. GMP/GDP has become second nature to me. While I consider quality to be of the utmost importance in terms of product quality and patient safety, I always take a pragmatic approach. Unfortunately, organizations often lack pragmatism, which is why they become bogged down in cumbersome quality systems that limit their ability to respond quickly to operational work and business growth.
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My motivation to expand Allione into a broader consultancy firm is rooted in my firm belief that compliance and quality should never be compromised. I am strongly committed to promoting the idea that support in the areas of quality and compliance should therefore be easily accessible to every organization.
Ensuring quality and compliance is dependent on the implementation of effective systems that have a robust foundation. From these systems, processes can be established to guarantee product quality without unnecessary complexity. My goal is to assist organizations in implementing quality control measures in this manner.
By offering Q specialists and organizations the opportunity to quickly call in support when needed, results can be achieved quickly, preventing compromises in quality and compliance.
Further I like to work in a dynamic (virtual) environment and being part of the daily operation. That is why another part of my business involves supporting (virtual) companies, like pharmaceutical product importers, in implementing robust quality management systems. I assist these organizations by managing their contract manufacturing organizations (CMOs) to ensure regulatory compliance of their products. In addition, I offer Qualified Person (QP) services to ensure the availability of pharmaceutical products within the EU.