Sterility Assurance Quality Specialist (Pharmaceutical) job opportunity at Capgemini SE.

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Capgemini SE Sterility Assurance Quality Specialist (Pharmaceutical)
Experience: Professional
Pattern: Permanent
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Hiring inbound within Diegem

At Capgemini Engineering, the world leader in engineering services, we bring together a global team of engineers, scientists, and architects to help the world’s most innovative companies unleash their potential. From autonomous cars to life-saving robots, our digital and software technology experts think outside the box as they provide unique R&D and engineering services across all industries. Join us for a career full of opportunities. Where you can make a difference. Where no two days are the same.Job DescriptionAs 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 profile6+ 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 hereContinuous 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.Capgemini is a global business and technology transformation partner, helping organizations to accelerate their dual transition to a digital and sustainable world, while creating tangible impact for enterprises and society. It is a responsible and diverse group of 340,000 team members in more than 50 countries. With its strong over 55-year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs. It delivers end-to-end services and solutions leveraging strengths from strategy and design to engineering, all fueled by its market leading capabilities in AI, generative AI, cloud and data, combined with its deep industry expertise and partner ecosystem.

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