Mirjam Zelhorst
Consultant
Expertise
Mirjam joined Progress in May 2021. With her technical background (HTS) she started working in the pharmaceutical industry in 2003 as Supervisor Maintenance of the Blister Packaging department at Merck Sharp and Dohme (MSD). In 2008 she switched to the Quality department of Sanquin Plasma Products as a (Senior) Quality officer. She gained a lot of experience on (GMP/GDP) quality systems in various roles. She was involved in e.g. change control, deviation and CAPA management, document control, complaints handling, batch record review, audits and intermediate product release.
In her role as (lead) auditor, Mirjam frequently traveled around the world for supplier audits and assessments of various business processes. She is also experienced in the preparation and facilitation of inspections (e.g. IGJ and FDA). Before joining Progress she worked as a Senior Quality Officer at the QA department of the Pharmacy of the Dutch Cancer Institute – AVL. She was responsible for the management and monitoring of the work processes within the pharmacy (updating and writing GMP documentation, deviations, CAPAs, change control, complaints, management review, PQR, supplier qualification, data integrity and (internal) audits.
Due to her work experience in both Production and Quality Affairs roles Mirjam is pragmatic and always finds a good balance between Production and GxP guidelines.
Personal
Mirjam is married and has a daughter. In her spare time she likes to work in the garden, walk or read a book. For her favorite sports you can find her in the gym for a heavy bag or kettlebell workout. During weekends or holidays she enjoys mountain biking, swimming and skiing.
Specialties
- QA Support (Systems / Operations, Warehouse / Distribution)
- Internal and External Audits
- Inspection Readiness
- GMP Manufacturing (Packaging)