Specialist Good Distribution Practices
Walloon Brabant – Contracting
#QA #compliance #GDP #GMP #documentation #clinical #coldchain #pharma
Our partner is looking for a Specialist GDP to reinforce its teams. Our partner is a well-known pharmaceutical industry.
What are your responsibilities?
As a Specialist GDP, your main tasks will be:
1/ Review and Approval of GDP documentation used in the frame of IMP Clinical Supplies :
- Review of Supply Flow aligned with Logistical Strategy and Qualified status of Logistic Supply Partner,
- Review of feasibility assessment for the transfer between Commercial Sites, R&D Sites and CMO or between Clinical Sites to ensure product quality is kept at receipt as well as the Third Parties compliance.
2/ Writing and/or Review of Cold Chain documentation:
- Documentation provided to CMO / CRO to confirm storage condition and allocate Cold Chain budget for their activities;
- Confirmation of Cold Chain budget remaining for Clinical Sites’ activity at Release stage
- Assessment of temperature excursion during storage and/or distribution of IMPs
Who are you?
You hold a degree in sciences. You have a relevant experience in quality assurance in the pharmaceutical industry. You have a good knowledge of cGMP and GDP. You speak fluently French and English. You are a good communicator, autonomous, team player, rigorous and structured.
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]