QV specialist

My career path to become a QV specialist

News | December 2022 Quality control
Amélie Theodat Alispharm

After an engineering degree in industrial biology and a first experience in the pharmaceutical industry in microbiological quality control, I joined Alispharm as a consultant in 2020.

My first mission

My first mission was to validate the cleaning and sterilization processes of hip prostheses and their associated surgical instruments. I then continued in the medical device sector, working on risk management for spinal prostheses. I worked in collaboration with the Design Office, Production, Regulatory Affairs and Quality departments.

Later, I returned to the pharmaceutical industry for a while, working in the packaging development department for veterinary vaccines. This mission was both in the laboratory with packaging and product stability studies and in relation with packaging suppliers. I then went back to the MD sector in the regulatory affairs department. I was in charge of the international registration of products following a move of the production area. In parallel to my missions, I led training sessions on technical points such as qualification/validation, risk management and MD development for consultants who needed help on these subjects.

How I entered the technical direction

Since 2022, I joined the technical department to continue to help the consultants in their missions. I am also in charge of a Q/V platform to provide technical support to manufacturers on the realization of their QV exercises.

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