Batch documentation specialist

Our client, a biotech company, located in Zwijnaarde.

For our client, a pharmaceutical company in the Ghent region, we are looking for an administrative employee. In this role, you will be responsible for managing the lifecycle of documents linked to the production process. Each step must be documented and archived. You carry significant responsibility to ensure that everything is strictly carried out according to procedures:

• You communicate the up-to-date status of reviews and update status tracking spreadsheets.


• You assist in correcting errors in the documents, in line with GMP (Good Manufacturing Practices) and SOP (Standard Operating Procedure) guidelines.


• You provide documents such as batch records*, labels, forms, etc. Ensuring they are printed and available for production.


• You perform an initial quality check on available batch records and verify the completeness of all documents.


• You retrieve documents from archives to meet client requests.


• You assist with audits (both internal and external) and collaborate closely with quality staff to promote data integrity and GMP compliance.


• You initiate further investigation in cases of product non-conformity or when deviations occur.

*Batch records include documents related to the issuance, review, release, and reconciliation of a batch. Creating a batch is a step-by-step production process for manufacturing a pharmaceutical

For this administrative role, we are looking for someone with a strong sense of responsibility and excellent detail-oriented skills:

• You hold a Bachelor’s or Master’s degree, or have relevant experience.


• You have excellent communication skills in English (both written and spoken).


• You are proficient in using MS Office and can quickly learn new programs.


• You have a First Time Right approach and a hands-on mindset, with the mental flexibility to switch between different tasks and re-prioritize when needed.


• You possess strong organizational skills.


• You are a team player who can quickly and accurately communicate important information to the right department.


• You can perform well in a fast-changing environment, where meeting deadlines is critical, and flexibility is a must.


• You are able to work in a rotating shift system; you will work 4 days and then have 4 days off. The shifts are (6:00 AM - 4:00 PM, 8:00 AM - 6:00 PM, 10:00 AM - 8:00 PM, 12:00 PM - 10:00 PM, 2:00 PM - 12:00 AM, 3:00 PM - 1:00 AM, and 4:00 PM - 2:00 AM). Due to the rotation, you will work an average of 50% of weekends.