Anna-Myra Koopmans, pharmacist, MSc

Anna-Myra Koopmans, pharmacist, MSc

Director Quality Assurance and Qualified Person

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Joined BioConnection in 2016

Anna-Myra studied Pharmacy at the University of Utrecht where she obtained her Pharmacist-degree in 1991.
From 1991 until 2015 Anna-Myra worked for Organon/Schering Plough/MSD. The first 20 years she had several functions as Quality Assurance Officer, Production pharmacist and she managed the Quality Systems department. In all positions Anna-Myra’s main focus was on commercial parenteral aseptic production. She also was Quality lead for the project to build a new Parenteral and Polymer production facility.
In 2011 Anna-Myra transferred to the MSD pilot plant, (also known as the RY building currently in use by BioConnection) for clinical supplies and small scale commercial products. Anna-Myra last role for MSD was being the Qualified Person for the same RY building.

In 2016 Anna-Myra joined BioConnection when the RY building was transferred from MSD to BioConnection.
In her role as Director QA/QP she is responsible for building and maintaining the Quality Management System. In 2016 this system was approved by the Dutch authorities (EMA). In 2017 the Quality department is extended with a small microbiological and IPC-analytical laboratory which was approved in April 2017. In 2018, 2020 and 2023 BioConnection hosted successful FDA inspections. The latest inspection of the Dutch (and EMA) authorities was in 2021 being a routine GMP/GDP inspection in combination with the successful site clearance of the new large scale filling line. This also resulted in the grow of the Quality department which currently is about 25 people (including the development team). Additionally as of January 2023 she is also responsible for EHS and HR.

“Being responsible for the quality department of BioConnection I am proud on the robust quality system we built and is maintained by our dedicated quality team. Our goal is to make compliant product of good quality to fully ensure patient safety. This goal is reached in close cooperation with our operations and engineering team, program management and our customers. This cooperation and open atmosphere is definitely valued by the customers. We have assisted different customers with different type of product (including personalized clinical materials, in different phases of development and sometimes very challenging production processes. This makes my role very exciting and make that there is never a dull moment.“