Nicolas Van Leeckwyck Email & Phone Number

Zedelgem, Be

Destelbergen, Vlaanderen, België

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.

Lessines

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

Destelbergen

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

Puurs, België

Gent, België

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

Oostduinkerke, België

Promotor: Apr. Annemieke Brackman

Belgian Coastline

Gent, België

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

Master Of Science (Ms), Industrial Pharmacy

Activities and Societies: Master's thesis at the division of Pharmaceutical Biotechnology: "Transciptome analysis of Daphnia magna exposed.

Master Of Science (Ms), Pharmaceutical Drug Development

Activities and Societies: Master's thesis at the division of General Biochemistry and Physical Pharmacy: "Hyaluronic acid coating.