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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.