Contracting – Walloon Brabant
#QA #validation #cGMP #compliance #qualification #deviation #capa #changecontrol
Our partner is looking for a QA Validation to join its team. This international company is well-known for its pharmaceuticals.
What are your responsibilities?
As a QA Validation, you will support the QSIM Quality Expert in reviewing and making the approval of several documents linked to Single Use Systems qualification (FMEA, URS, VMP, DQ, IOQ (protocols and reports), VSR, other associated documents). To be successful in your role, here are your tasks:
- Ensure proper execution of the validation and application of cGMP (Validation Master Plan, Design Qualification, Commissioning, Installation & Operational Qualification and Validation Reports).
- Oversight the commissioning and qualifications during a project
- Review and ensure the compliance of the qualification protocols, review the commissioning and qualification raw data and finally approve the reports for conformance
- Must be able to give advices to the various actors in case of risks, issues or deviations
- Ensure that all GMP requirements are met during the project.
- GMP documents, procedures review and approval,
- Change control, Deviations, CAPA tasks review and approval
- Communicate quality issues to stakeholders through appropriated escalation processes. Understand and manage actions of mitigation if needed.
- Understand and manage current regulatory requirements, as well as internal, environment related to incoming materials.
- Support team members on specific activities.
Who are you?
You hold a master’s degree in sciences or a technical field. You have experience in quality or compliance environment in the pharmaceutical industry. You speak fluently French and English. You are autonomous and you have an analytical and synthetic mind.
What can you expect?
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way.
You’re interested in this job? We kindly invite you to apply. Do you have any questions? You can contact Marie Defruit, [email protected]