Sterility Assurance Quality Specialist | Life Sciences

Job Description

As a Sterility Assurance Quality Specialist, you will play a crucial role in ensuring the highest standards of quality and compliance in pharmaceutical manufacturing processes. You will work closely with cross-functional teams to drive continuous improvement initiatives and maintain sterility assurance standards that meet regulatory requirements.

In this role you will play a key role in:

• Driving and executing continuous improvement projects and remediation plans related to sterility assurance, including change control management and SOP reviews.
• Managing relationships with aseptic operations teams to ensure compliance with quality standards and regulatory requirements.
• Identifying potential quality and compliance risks and implementing strategies to mitigate these risks through existing quality systems.
• Performing gap analyses, system effectiveness reviews, and other management reviews to ensure ongoing compliance.
• Maintaining cGMP standards in your area of responsibility through proper documentation, audits, training, and method validation.
• Implementing and supporting adequate training programs related to sterility assurance, including shop floor mentoring to enhance operational excellence.

Your profile

• 6+ years of relevant experience in sterility assurance within the pharmaceutical industry and demonstrated expertise in Quality Assurance practices and GxP compliance.
• PhD or Master's degree in Sciences (Microbiology, Engineering, Bio-engineering, Pharmacy) or equivalent experience.
• Strong understanding of pharmaceutical manufacturing processes and regulatory requirements.
• Experience working with cross-functional teams to implement quality improvement initiatives.
• Hands-on approach with a coaching and mentoring style to positively impact individual experiences.
• Fluency in English required; French language skills are advantageous.

What you'll love about working here

• Continuous feedback: We take a human-centric approach to foster growth and performance. Our performance management tool GetSuccess enables continuous feedback, quarterly check-ins with managers, and ongoing performance discussions.
• Hybrid working: We encourage flexibility when it comes to when and where work 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 unleash their R&D potential to develop smart products and services of tomorrow.