Over Simon
Engels
Tweetalig / moedertaal
Frans
Tweetalig / moedertaal
Werkervaring
- UCBVendor Quality Partner - Qualified PersonBIOTECHNOLOGIEjanuari 2024 - Vandaag (2 jaren en 7 maanden)Braine-l'Alleud, BW, BelgiumProviding QA expertise for CMO Quality oversight.Form : Oral SolutionExperience :• Deviation process• Product Quality Review• Change Control• Batch review• SOP management• Quality Agreement• KPI monitoring• Complaints• RA requestAct as a Qualified Person for UCB Global department.Forms : Patches, Oral solutions
- UCBVendor Quality Supportoktober 2022 - januari 2024 (1 jaar en 3 maanden)Braine-l'Alleud, BW, BelgiumProviding QA expertise and support to the Global Vendor Team for UCB External Manufacturing. Experience :• Deviation process• Product Quality Review• Change Control• Batch review• SOP management• Quality Agreement• KPI monitoring• Complaints• RA request
- LE VAL DU GEERQualified Person & QA/QC Managerseptember 2021 - september 2022 (1 jaar)Act as a Qualified Person & QA/QC Manager in a primary & secondary packaging pharmaceutical industry. QA/QC experience- In charge of QMS (managing deviation, CAPA, change control, complaints, SOPs, formation of people).- Validation of process & qualification of equipment- Batch reviewing & in process release.- PQR- Risk Management & Analysis- Managing 2 QC technicians & 1 QA assistant- Supervising the QC testing- A little experience of CSV ( was the QA member in the team project)QP Experience- Certification of batch records- In charge of the application of cGMP on the production site- Regulatory responsible in touch with the belgian autorithies- Recognize by the belgian authorities ( QP number)
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Opleidingen
- Master of Advanced StudyUniversité de Liège2021Advanced Master's, Pharmaceutical Industry
- Master's degree, Pharmaceutical sciences : Drug conception and development - BioanalysisUniversité de Liège2020Master's degree, Pharmaceutical sciences : Drug conception and development - Bioanalysis
Diploma's
- Qualified PersonAFMPS2022