Expert Solid State & Non-Chromatographic Analytical Technologies
Life Sciences
QA
Bachelor, Master
Advanced (5+)
- Emplacement
- Geel, Anvers
- Type de travail
- Consultancy
- Modèle de travail
- Fulltime, Hybrid
Our client, a leading pharmaceutical organization, is seeking an expert to provide comprehensive oversight of non-chromatographic quality control laboratories. This role involves driving analytical excellence, ensuring regulatory compliance for small molecule APIs, and leading strategic improvement initiatives within a global manufacturing environment.
Responsabilités
- Provide scientific oversight and coaching to laboratory personnel on technical matters related to non-chromatographic analytical fields.
- Lead complex scientific investigations and cross-functional quality remediation plans, including the development of CAPA strategies.
- Drive systematic changes by creating change controls and facilitating the implementation of new procedures and guidance documents.
- Develop and review GMP procedures and standards to ensure scientific excellence and regulatory compliance in a commercial environment.
- Manage analytical method transfer activities and act as system owner for an extensive laboratory instrument park.
- Monitor laboratory practices to ensure alignment with industry trends, regulatory expectations, and global standards.
- Represent the quality control department during authority inspections and facilitate compendial vigilance for EP, USP, and JP updates.
Exigences
- You have a Master's degree in Chemistry, Pharmaceutical Sciences, or a related scientific field.
- You bring 5+ years of experience in small-molecule CMC analytical areas, specifically within analytical R&D, MSaT, or industrialization.
- You possess in-depth knowledge of cGMP principles and ICH guidelines including Q1, Q2, Q7, and M7.
- You have advanced scientific expertise in non-chromatographic technologies such as XRPD, laser diffraction, Karl Fischer (KF), IR spectroscopy, and ICP-OES/MS.
- You're experienced in analytical method validation, stability testing, and analytical method transfer processes.
- You bring strong interpersonal skills with the ability to influence and partner across organizational boundaries.
- You are fluent in English with a good understanding of Dutch.
Nice to Haves
- Possession of a PhD in a relevant scientific discipline.
- Experience with chemometrics, PAT, or RTRT methodologies.
- Familiarity with different phases of pharmaceutical development and Quality Risk Management principles.
Offre
- Bénéficiez d'un package salarial compétitif avec des avantages supplémentaires qui récompensent votre talent.
- Faites évoluer votre carrière avec un parcours clair, du coaching et du mentorat pour vous accompagner.
- Épanouissez-vous dans un environnement dynamique et bienveillant où vous pouvez réellement faire la différence.
- Travaillez où et quand vous êtes le plus performant pour un équilibre travail-vie optimal.
- Optez pour une solution de transport flexible, d'une voiture de société à un abonnement aux transports en commun.
- Développez votre réseau et vivez des moments inoubliables lors d'événements exclusifs et afterworks.
- Développez vos compétences grâce à des formations externes et notre Pauwels Academy interne.
- Travaillez sur des projets stimulants avec des leaders dans les domaines Life Sciences, Engineering & Digital.
- Saisissez des opportunités à tous les niveaux, d'un excellent départ à une progression rapide et une collaboration experte.
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