
Sterility Assurance Quality Specialist
Minor Hotels Europe and Americas
full-time
Posted on:
Location Type: Hybrid
Location: Diegem • Belgium
Visit company websiteExplore more
About the role
- Leading and executing material qualification processes for excipients used in new and existing pharmaceutical products
- Implementing and maintaining robust change control systems to ensure regulatory compliance and product quality
- Collaborating with R&D, Quality Assurance, and Supply Chain teams to align on material specifications and project timelines
- Preparing and reviewing technical documentation, qualification reports, and regulatory submissions related to material science
- Providing expertise on raw material characterization, supplier qualification, and conducting comprehensive risk assessments
- Supporting troubleshooting efforts and driving continuous improvement initiatives in pharmaceutical material sciences
Requirements
- Bachelor's or Master's degree in Pharmaceutical Sciences, Chemistry, Material Science, or related scientific field
- Minimum 3 years of experience in material qualification within the pharmaceutical or biotech industry
- Strong knowledge of excipient qualification processes, material characterization techniques, and change control procedures
- Experience with GMP regulations, ICH guidelines, and pharmaceutical quality systems applicable to raw materials and excipients
- Demonstrated ability to manage multiple projects simultaneously while maintaining attention to detail
- Excellent communication skills with the ability to present complex technical information to diverse stakeholders
- Experience with risk management methodologies and quality-by-design principles in pharmaceutical development.
Benefits
- Hybrid working: We encourage flexibility when it comes to when and where works gets done.
- Free access to learning platforms: Free access for all to world-class learning assets and curated programs from Harvard Business Review, Coursera, Pluralsight, Udemy, Microsoft, AWS, Google and many more.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
material qualificationraw material characterizationsupplier qualificationrisk assessmentschange control proceduresGMP regulationsICH guidelinespharmaceutical quality systemsquality-by-design principlesmaterial characterization techniques
Soft skills
project managementattention to detailcommunication skillscollaborationtroubleshootingcontinuous improvementpresentation skills
Certifications
Bachelor's degree in Pharmaceutical SciencesMaster's degree in Pharmaceutical SciencesBachelor's degree in ChemistryMaster's degree in ChemistryBachelor's degree in Material ScienceMaster's degree in Material Science