For one of our client located in the Walloon Brabant, we are looking for an enthusiastic and experienced QA Packaging Associate.
Do you have a University Degree in Life Sciences?
Do you have a first experience in a QA position within the pharmaceutical industry?
Are you fluent in English and in French (oral and written)?
If this applies to you, don't hesitate to contact us and/or send your CV!
As a QA Packaging Associate, you ensure the Quality oversight of packaging and labelling operations of Clinical Trials performed by Contracting Parties (Third Parties) and Alliance Partners located in the EU and Asia in compliance with both regulatory and Corporate GMP/GDP requirements of Clinical Trial supplies. You ensure compliance with EU and Belgian regulatory requirements and with GMP/GDP of activities performed on behalf of the company.You work with key members of the Global Quality Development Unit and Regulatory Affairs.
1. GMP/GDP compliance and Batch certification (packaging operations)
- You ensure all QA activities are performed in compliance with applicable GMP/GDP and regulatory requirements for Investigational Medicinal Products (IMP).This includes, but it is not limited to: maintaining familiarity with the production processes, participating in deviation investigations, reviewing trending outputs, reviewing DCPR
- You provide training to the staff
- You conduct self-inspections
- You provide input into controlled change
- You ensure appropriate obtained samples are being kept
- You participate in regulatory inspections
- You review and approve instructions for packaging/labelling operations and packaging/labelling batch records for studies performed by the different contracting parties and alliance partners
- You review results raised by the analytical laboratory/ies
- You participate in reviewing and approving deviations and change controls related to the packaging/labelling of Clinical Trial Material
- You participate in Person-in-Plant when required
- You assure that temperature excursions are investigated and documented
- You create a direct link between the company and third parties for quality activities
- You update the Quality Manager of any non-conformity and/or issues that may affect quality and/or integrity of the Clinical Trial Materials (finished and/or semi-finished)
- You review and approve master label
- You review and approve procedures, tools or any other documents that require QA approval
- You actively participate in populating the company’s databases used in packaging department, this includes but not limited to: Syteline, PMX, SAP, TrackWise, Metrics Database
- You are in charge of the documentation management
- You have a unversity degree in Life Sciences (in pharmaceutical sciences or in quality management)
- You have a first experience in a QA position within the pharmaceutical industry
- You have a first experience in QA batch release
- A first experience in Clinical Trials is an asset
- You are fluent in english and in french (oral and written)
- You particularly appreciate tasks linked to the management of the QA documentation
- You are a strong team-player, you have a strong anlytical mind and you are proactive
- You are eager to learn within a changing regulatory environment
+32 2 588 16 07