Batch Record Reviewer
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 Description
We are looking for a Batch Record Reviewer to join our team. In this role, you will ensure the accuracy and completeness of production and cleaning batch documentation, supporting compliance with GMP standards.
Key Responsibilities
- Review production and cleaning batch records in detail for completeness and accuracy.
- Generate batch trending reports and verify data integrity.
- Complete documentation with necessary attachments (e.g., eLIMS results).
- Verify correct consumption of raw materials and identify discrepancies.
- Check and classify deviations according to procedures; initiate non-conformance reports when necessary.
- Archive batch records in compliance with internal standards.
- Collaborate closely with operations and quality teams across departments.
Your profile
- Bachelor or master’s degree in Chemistry, Pharmaceutical Sciences, Industrial Engineering, Biotechnology, or equivalent experience.
- Previous experience in GMP/GDP environments, preferably in pharmaceutical or chemical manufacturing.
- Knowledge of GMP and documentation practices.
- Familiarity with batch records and deviation handling.
- Experience with eLIMS or similar systems.
- Strong attention to detail and analytical mindset, excellent communication and collaboration skills.
- Excellent communication skills in English & Dutch.
What You Will Love About Working Here
- At Capgemini Belgium we offer flexibility in more than one way: next to our hybrid way of working, where we offer you can work 70% from home, we also offer our flex abroad program. With this program you can work up to 45 days abroad, this to maintain a good work-life balance.
- Our mission is your career path. Our array of career growth programs and diverse professions are crafted to support you in exploring a world of opportunities.
- OUTfront, Women@Capgemini or CapAbilityare 3 examples of employee led networks dedicated to advance diversity, equity and inclusion within workplace and society.
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.
Diegem, BE