GMP Compliance
Brabant Wallon – contracting
Our partner is looking for a GMP Compliance to provide support. This international company is well-known for its pharmaceuticals and vaccines.
What are your responsibilities?
- Perform the preliminary evaluation, record and acknowledge receipt of the reported complaint
- Analyze, Coordinate investigations of Manufacturing sites and provide an investigation report (interim/final) for the received complaints in accordance with quality agreements specific to each partner
- Manage the logistic related to samples: complaint sample description, testing and archiving / retain sample testing
- Define complaint management strategy for specific defect trends
- Ensure the day to day contact with the partners
- The main function is to autonomously support the team in their day-to-day activities and to bring support on tasks related to adjuvant for pandemic vaccines
- Be the interface between partners commercializing vaccine worldwide with our adjuvant, global functions and manufacturing sites
- Be the main interlocutor when some additional information is needed
- Challenge manufacturing site investigation and summarize the investigation to the reporters
- Take the ownership on complaint management improvement
Who are you?
- Prerequisites University degree in Sciences (e.g., Bio Engineer, Biologist, Chemist)
- Biological manufacturing processes and SAP knowledge is an asset
- Minimum 3-4 years of a proven experience in a GMP environment (preferably in relation with deviation or complaint handling)
- Fluent in both English and French, spoken and written
- Customer oriented (interface with partners)
- Ready to work in a global and complex organization (open minded, flexible and quality mindset)
- Be capable to adapt to the situation with a certain level of uncertainty
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 Rossenfosse : [email protected] or +32494/91.87.40