AKKODIS Belgium is looking for an experienced person in a pharmaceutical environment in the field of validation.

Your responsibilities :

- Ensure the execution or review of the required pre-tests before starting the final implementation of new processes.

- Coordinate all GMP documentation required for change control management (VP - TCD - VSR - QAGMP authorisation - QAGMP approval - external quota documentation, etc.).

- Write or revise PQ validation protocols and reports and analyse the results during PQ runs.

- Ensure the planning of validations in partnership with the C&M/QA departments and production - Ensure communication with the production team in order to have the raw materials/assemblies/ad hoc resources for the validation.

- Ensure the operational management of the technicians dedicated to validations.

- Ensure all deviations related to the implementation of the change.

- Ensure the follow-up of QC results for each validation cycle. - Ensure timely collection/transfer of approved local documents to the RA department to ensure timely submission.

- Ensure review of dossier preparation in partnership with QA prior to submission of dossier to authorities.

Your profile:

- You have a master's degree in industrial biology/chemistry or an industrial pharmacist title.

- You have experience in project coordination in a pharmaceutical environment. A previous technical background is a plus.

- You have experience and technical skills in the pharmaceutical industry.

- You are fluent in French and English.