Multinational Clinical Trail Supply company with locations in Belgium, Germany and North America requires a Qualified Person (QP) to work alongside the quality team.
The companies professionalism, customer service standards and employee satisfaction has lead to massive expansion. Therefore they require a QP who will work within the Quality team reporting to the QA Manager to take an active role helping maintain this growth.
- Batch certification & release of medicinal products & maintain a batch certification register EU import of IMP
- Verify/evaluate GMP manufacturing documentation
- If applicable, perform GMP audits to proof that the medicinal products have been manufactured and tested according to EU GMP
- Ensure that company services are delivered on time, within budget and according to the agreed quality standards
- Establish the technical/quality agreements between the company – customers and – subcontractors
- Take part in the overall improvements of internal processes and systems
- Contribute to the quality department’s activities to ensure continuity of operation. Coordinate information collection via “quality questionnaires” sent to suppliers and subcontractors.
- Qualification as Qualified Person mandatory
- Experience as a QP of 2-5 years
- IMP experience of 2 years mandatory
- Experience in manufacturing, packaging & labelling and/or supply chain
- GMP-GDP-GCP knowledge
- French & fluent in English
- Good computer skills : Word, Excel, Outlook, Powerpoint
- Assertiveness and diplomacy
- High organizational and planning skills
- Excellent verbal and written communication skills
- Team worker and team spirit
- Customer oriented
- Eagle eye for details
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