GMP Compliance
Brabant Wallon – contracting
Our partner is looking for a GMP Compliance to join its team. This international company is well-known for its pharmaceuticals and vaccines.
What are your responsibilities?
You will ensure specific follow-up of risky suppliers and incoming materials throughout:
• Define, follow and communicate specific KPI associated to risky suppliers.
• Manage supplier change notifications to ensure appropriate review and implementation. Manage all common and most critical changes, and escalate issues if required.
• Escalate suppliers/quality issues to stakeholders through appropriated escalation processes. Manage actions of mitigation (QEF, BPDR, …).
• Manage some investigations (deviations and market complaints) in partnership with TLCT, QC, Belgium manufacturing facilities and suppliers to identify and follow up root causes and CAPA’s, as well as product impact assessment.
• Understand and manage autonomously quality aspect of suppliers and materials qualifications in partnerships with key stakeholders (procurement/TLCM/QC/Engineering). Manage implementation of Quality Agreements and negotiation of product specification requirements.
• Support supplier quality system audits on request and assess supplier capability to meet product requirement specifications. Manage supplier quality risks and areas for improvement to ensure actions are incorporated into supplier corrective and preventive action plans. Manage supplier approval processes and suppliers corrective and preventive action plans to completion.
• "Promote a customer focus spirit. Cultivating a network of collaborative internal relationship and supplier network.
• Promote continuous improvements and customer focus spirit"
• Serve as a Site Liaison to provide an effective link between the site business needs and the QASIM department to ensure full understanding of site requirements, priorities, issues and provide support to the sites during internal and regulatory inspections.
• Understand and manage autonomously quality aspect of suppliers and materials qualifications in partnerships with key stakeholders (procurement/TLCM/QC/Engineering). Manage implementation of Quality Agreements and negotiation of products specification requirements.
Who are you?
- You hold a bachelor’s degree or a master degree
- You have at least 3 – 5 years of relevant experience
- Good written and oral presentation capability in English
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 Aurélie Montes Suarez: [email protected] or +32472/44.83.18
