• QC Equipment Validation
• GMP
• Ph. Eur
• Empower software
• Change control
• Validation deviations
• CAPA’s, SOP’s
• Galenic formulations
• Chromatography and Spectrophotometry
• ICP
• Titration
• PSD
• Chemical tests

Job function:

• Expertise in HPLC/GC en grondstof analyse vereist (FTIR, raman, spectrofotometrie, refractometrie, densitometrie,...)
• Expertise in Ph.Eur, USP en JP pharmacopeal testing requirements
• Bereid om hands-on werk uit te voeren in kader van method implemenatie/validatie
• Ervaring met Equipment validatie en data integrity requirements voor complex QC equipment en software bv HPLC, plate reader,
• User Requirements Specifications (URS).Installation qualification (IQ) en Operational qualification (OQ), Performance qualifications (PQ)
• Participeert in analytical method transfers en/of validaties: GAP assessments, SOP creatie en bijhorende trainings geven voor nieuwe methods
• Een pluspunt indien er ervaring is met digitalisering van de werk flows (in kader van paperless lab transformatie)

Skills

• GMP experience in pharma
• Technical skills through experience
• Analytical thinking
• Teamworking
• Result oriented
• Good documentation and writing skills in English.

Profile

• Master in chemistry with at least 5 years experience in GMP
• Minimum trained profile