This position is accountable to perform and document all necessary investigations to support assessments of the purchased products are meeting internal and external quality and regulatory standards and are manufactured and released in compliance with current PQS, purchase specification, MDCP, GMP and regulatory requirements. This position is the primary contact for operations (production, warehouse, packaging, lab, supplier, procurement, STS, ..) in case of quality deviations related to purchased materials.
* Act as an expert of all matters related to supplier management.
* Follow up of the quality performance of the suppliers through (re)qualification, key account meetings, supplier evaluation meetings, audits, etc...
* Participate in projects linked with purchased materials
* Follow up on actions defined in the CAPA management system to assure quality/compliance improvements of manufacturing processes of pharmaceutical and MDCP products.
* Act as primary contact during inspections for topics related to supplier management and other related topics.
* Prepare quarterly trend reports.
* This position can be requested to participate in assignments defined by the Team Leader Supplier Quality or Sr. Manager Release Operations.
Languages : Dutch & English (professional working proficiency)
Expected level of experience (junior, medior, senior?)
Junior
Specific skillsets needed
Good analytical and problem solving skills.
Excellent oral and written communication
Human interactions (diplomacy, convincing, assertiveness,..)
Excellent documentation skills (technical report writing)
Good time management skills and prioritization skills
Must haves
Master’s degree: pharmaceutical and/or biological manufacturing or scientific field (Following, although not limiting, educations are acceptable: Bio Engineer, (Industrial) Pharmacist, Master in Biology, Biochemistry, Biotechnology, Engineering, ...)
Or Equivalent by working experience
Assets
* Expert/ Specialist in the process requirements (PQS, Regulations,...)
* Excellent knowledge and understanding of cGMPs and relevant medical device and combination products regulations
Estimated duration of service
7/02/2026