As Qualified Person, I was responsible for batch release and batch certification of non-sterile medicinal products (liquids and semi-solids) and authorised raw materials. As QA manager, I was responsible for the Quality Management System related to medicinal products, medical devices and other types of health care products in compliance with cGMP, GDP, HACCP and ISO13485.

As QP, I was responsible for the release of medicinal products destined for several countries within the EU and UK. As Quality manager, I was responsible for the Quality Management System of manufacturing and distribution activities for industrial, foodgrade, and medical gases.Key Achievements are:- Getting the company out of "GMP Compliance management" status with favourable outcome after 2 years;- Significant increase in efficiency of performing time-consuming activities such… Show more As QP, I was responsible for the release of medicinal products destined for several countries within the EU and UK. As Quality manager, I was responsible for the Quality Management System of manufacturing and distribution activities for industrial, foodgrade, and medical gases.Key Achievements are:- Getting the company out of "GMP Compliance management" status with favourable outcome after 2 years;- Significant increase in efficiency of performing time-consuming activities such as data collection, redaction of registers and invoice checks by automating these processes;- Vast reduction of the occurrence of issues throughout the product lifecycle by setting up a documented receptionning system of all incoming critical products. Activities include, but are not limited to:- Ensuring GMP compliance and retaining the relevant authorizations (MIA and WDA);- Incorporating Quality Risk Management principles/tools in a vast array of activities to ultimatelyensure appropriate product realisation;- Training staff on GMP-, GDP- and GLP-related topics (initial and continuing training);- Frequent visits to the production/storage areas (floor presence) to verify activities andprovide support/feedback to the operators;- Ensuring and maintaining a state of control regarding product output and quality;- Validation & qualification of manufacturing equipment and processes, lab equipment and software (writing protocols/reports);- Execution of internal audits and supplier audits;- Providing support on complaint and deviation handling and redaction of change controls;- Maintaining an up-to-date Site Master File;- Annual redaction of Product Quality Reviews (data gathering, analysis and presentation in a clear and accessible way)- Prompt Batch Release Show less

As QA associate, I was responsible for several aspects of the Quality Management System. Using my knowledge of pharmaceutical packaging and production activities I carried out extensive deviation handling. I was also responsible for the CAPA-system and I helped employees in keeping up high GMP-standards during production and packaging activities using face-to-face communication and group trainings. I have improved efficiency of packaging activities by setting up new systems (IPC… Show more As QA associate, I was responsible for several aspects of the Quality Management System. Using my knowledge of pharmaceutical packaging and production activities I carried out extensive deviation handling. I was also responsible for the CAPA-system and I helped employees in keeping up high GMP-standards during production and packaging activities using face-to-face communication and group trainings. I have improved efficiency of packaging activities by setting up new systems (IPC, Line-Clearance, Cleaning,..). Show less

Laboratory of Pharmaceutical BiotechnologyPromotor: Prof. Dr. Apr. D. Deforce

Promotor: Apr. Annemieke Brackman

Laboratory of General Biochemistry and Physical PharmacyPromotor: Prof. Dr. ir. S. De Smedt