QA GMP Compliance
Brabant Walloon – Contracting
What are your responsibilities?
- Manage the qualification of incoming materials and suppliers (compliance requirement and validation aspects)
- Manage change received from the supplier
- Manage a collaboration with the suppliers in order to ensure quality of suppliers, service providers and Incoming materials and to ensure that internal quality requirements and expectations are taken into consideration.
- Understand and deploy regulatory constraints (GMP, ISO …), as well as internal procedures, related to management of incoming materials (e.g. compliance qualification quality agreement,…)
- Manage deviation and CAPA
- Perform and follow material qualifications in partnership with the project team
- Communicate suppliers/quality issues to stakeholders through appropriated escalation processes.
- Understand and manage actions of mitigation if needed.
- Understand and manage current regulatory requirements, as well as internal, environment related to incoming materials.
- Support team members on specific activities.
Who are you?
- Education in a relevant scientific, quality or technical discipline.
- Be able to understand main regulatory constraints and main vaccines manufacturing processes.
- Knowledge of regulatory and quality system requirements and ability for the supplier to comply with standards.
- Good verbal and written communications skills in French and English to ensure issues, risks and opportunities are well understood by all parties and that effective actions are put in place.
- Ability to function efficiently in a matrix organization in order to ensure effective communication of issues to all impacted sites /functions.
- Understand negotiations related to implementation of appropriate
- Regulatory requirements and quality standards.
- Experience with Microsoft Office applications and have the ability to learn new software applications such as SAP.
- Understanding of technologies used within the material supply base.
- Understanding of cGMP regulatory requirements and standards
What can you expect?
We offer you an open-ended contract as well as an attractive salary package. You will also take advantage of the opportunity to develop yourself personally and professionally through internal training.
Interested? Do not wait any longer!
Apply directly via our website WWW.JEFFERSONWELLS.BE or send your CV to the following email address [email protected]
