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As a Quality Engineer Release / back-up Qualified Person, you make sure to guarantee quality with a number of QP responsibilities. This is done by monitoring and ensuring that all operations at all levels take place according to the cGMP quality systems applied by our client. You ensure our client’s products can be released on time and that the quality systems meet both European and American cGMP guidelines.
Why should you be interested?
- If you are concerned by the generous blood donators and the yearly 3.5 million international donations received by our clients through dedicated partners .
- If you are concerned to deliver services that will be helping patients worldwide with effective treatments that will improve the quality of their lives.
- If you want to join a center of excellence that develops , processes and manufactures protein therapies for leading pharmaceutical companies…
This job is for you and this company is the place where you should work!
- Prepare records for the release of plasma, raw materials, auxiliary materials and intermediate products (including certificates that guarantee traceability, viral safety and compliance of the products to be released);
- Prepare export records for shipments to technology partners of plasma products. This is according to the quality contract established between the two parties;
- Ensure contacts with technology partners for all the activities of the Department of release (delays in release, closing of files, release of products intended for the partner in question ...);
- Actively contribute to manage, improve quality systems
- After an intensive period of training, you will be the representative of the QP and you will have legal responsibility for the QP’'s act of proxy release.
- You hold a master's degree in industrial pharmacy;
- You have 4 to 6 years of experience in the pharmaceutical industry in this role;
- You have an accreditation number as a Qualified Person;
- You are familiar with the European and American GMP guidelines (Good Manufacturing Practices) and SOP's (Standard Operating Procedures);
- You have an excellent knowledge of English and French or Dutch; German is a plus.
- You are computer software literate (Windows, Word, Excel, Access);
- You are rigorous, methodical and structured;
- You are stress-resistant and you know how to cope with deadlines
- You want to invest in the long term in order to be able to evolve in the medium term towards more responsibilities in the function.
Building on 60 years of plasma fractionation history and processing 3.5 million international donations each year for a selected number of dedicated partners, our services help their patients worldwide to safe and effective treatments which improve the quality of their lives.
Ongoing investments in production, development and logistics guarantee the most up-to-date technologies and production facilities, to meet an increasing demand for life saving and changing proteins.
Their mission is to be a CDMO partner of choice for their clients' protein therapies.
The plasma industry has changed drastically over the years. To remain competitive, it is vital that all employees share the same clear vision of the future, based on the shared successes of the past.
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22 days left to apply
- Function type: Quality
- Sector: Chemistry and Pharmacie
- Neder-over-Heembeek (Bru.) (location)
- All jobs via Pauwels Consulting
- Master (University or Higher Education Long Type)
- Dutch, English, French
- Company car