Senior CQR Engineer

Senior CQR Engineer

Capgemini Engineering

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.

Your role

As a Senior Compliance, Quality & Regulatory (CQR) Engineer within our pharmaceutical practice, you will lead a specialized team of QA engineers, compliance specialists, and validation engineers. You will be responsible for ensuring the highest standards of quality and regulatory compliance in pharmaceutical manufacturing processes.

In this role you will play a key role in:

• Leading and mentoring a team of quality professionals, fostering a culture of excellence and continuous improvement
• Overseeing quality checks of production batches and ensuring strict adherence to operational procedures in accordance with GMP requirements
• Managing the implementation and execution of Corrective and Preventive Actions (CAPAs) to address quality issues
• Conducting and coordinating internal and external audits to ensure compliance with regulatory standards
• Developing and implementing risk assessment methodologies and root cause investigation processes
• Reviewing and approving document changes and change controls to maintain compliance
• Creating and updating Standard Operating Procedures (SOPs) and Validation Master Plans
• Collaborating with cross-functional teams to drive quality initiatives and resolve complex compliance challenges

Your profile

For this position it is important to have strong experience in quality assurance, compliance, or regulatory affairs within the pharmaceutical industry, with a proven track record of leading teams in a GMP-regulated environment. Your comprehensive knowledge of pharmaceutical quality systems includes:

• Strong knowledge of pharmaceutical quality systems, including risk assessments, CAPAs, and change control processes
• Experience in conducting root cause investigations and implementing effective corrective actions
• Proficiency in developing and reviewing validation documentation, including Validation Master Plans
• Excellent understanding of pharmaceutical regulatory requirements and industry standards

What you'll love about working here

• Engage in projects that directly impact industrial technology and innovation, where you can collaborate with top engineers and expand your expertise.
• Challenging projects in innovative, high-tech industries with a global impact.
• Access to career development programs, certifications, and digital learning platforms to support your growth.
• Flexible working hours and hybrid working options to support your lifestyle and well-being.
• An inclusive workplace recognized by Ethisphere as one of the World’s Most Ethical Companies.

Note

To ensure safety and integrity within our organization, an identity check and background check are part of the onboarding process.

Capgemini

Capgemini is a global business and technology transformation partner, helping organizations 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. The Group reported 2024 global revenues of €22.1 billion.

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