AKKODIS Belgium is looking for an experienced person in a pharmaceutical environment in the field of validation.
What are 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 - QA GMP authorization - 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.
Who are you?
- 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.
What’s the offer you can’t refuse?
As an AKKODIS Team Member, you will be:
• Onboarded in your position via a buddy process
• Supported in your career by your Business Manager
• Actor of your training plan and your personal and professional development
• Benefiting from a permanent contract
• Benefiting from a competitive salary package including several extra-legal benefits
Interested? I invite you to send me your resume to the following mail adress: