Contratcing – Walloon Brabant
#QA #quality #qualitymanagement #qualityassurance #qa #validation
Have you experience in quality? Do you speak fluently English? Are you a proactive person? Keep reading your future job description.
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 consultant, you will ensure the QA oversight and support Quality tasks linked to deployment of MES project. To be successfull in this role, her are your main tasks:
• To take part in the establishment of validation strategies linked to the implementation of the MES in MPU
• To ensure that the validation strategies is described in the change control process (CC),
• To write and implement some validation documentation (VP, VSR, Risk Assessment, Gap Analysis),
• To review and approve specific qualification and validation documentation (IQ, OQ, PQ, PV),
• To ensure the correct application of the validation quality systems on the field and to define improvement plan as required,
• To support the MPU in the implementation of the validation activities, potentials CAPA (be Compliance Authority).
• To identify ways of working (including best practices) to facilitate deployment in others MPUs.
• Challenge, review and approve qualification and validation (IQ, OQ, PQ, PV) documentation and ensure they are written in accordance with the vaccines standards and procedures.
• Write some validation (VP, PQ, PV, VSR, PVMP) documentation according to the Bio standards and procedures.
• Ensure adequate oversight and follow-up on the validation deviations both in terms of content (root cause and CAPA).
• Support from a compliance point of view the QA Operations for validation topics linked to MES implementation.
Who are you?
You have a good knowledge of good practices in biopharmaceuticals and of the different regulations and standards related to validation activities. You are a good team player and have good communication skills in order to success in each validation project. An experience in validation in the phamarceutical company is an asset.
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]