Sterility Assurance Quality Specialist | Life Sciences 1

Job Description

As a Material Qualification Specialist in our Life Sciences division, you will support Material Qualification and Product Development activities within the Therapeutics Development & Supply organization. Working closely with senior managers and cross-functional teams, you will ensure compliance, quality, and timely delivery of material science projects for pharmaceutical excipients and new medicines. This hybrid role offers 50% onsite/remote working arrangements.

In this role you will play a key role in:

• 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

Your profile

• 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

What You'll Love About Working Here

• Hybrid working: We encourage flexibility when it comes to when and where works gets done. Employees work with their managers to determine an arrangement that works best for their role and personal circumstances.
• 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.
• Worldwide Leader of Engineering Services: Capgemini Engineering combines its broad industry knowledge and cutting-edge technologies in digital and software to support the convergence of the physical and digital worlds. We help our clients unleashing their R&D potential to develop smart products and services of tomorrow.