quality assurance analyst.

Support of planning, execution, and documentation of the qualification and monitoring of suppliers who are sourcing API materials and Drug Product materials to the Janssen Supply Chain for the manufacture of API Intermediates, APIs, Excipients and Packaging Materials for the manufacture of Drug Products respectively.

Surveillance on the quality and compliance status for all third party supplied raw materials, intermediates, APIs, Excipients, and Packaging Materials.

• Support Account Owners on initial assessment and qualification of suppliers for new product introductions
• Support of change management, deviations, escalations, compliance issues, recalls, field actions that are related to suppliers
• Provision of all information needed for the release/reject of suppliers in SAP (SAP master data)
• Support establishment and periodic review of Quality Agreements
• Support establishment and revision of Qualification Statements, periodic performance metrics, and qualification classification for suppliers
• Execution of monitoring and trending reports for suppliers.
• Provides support to EQ Supplier Quality representative and subject matter expert during regular audits and health authority inspections
• Coordinate Supplier Specification Agreements and approval management
• Keep AIM (Auditee Information Management) records updated with any information related to material, qualification and monitoring activities

Interested in this vacancy? Send your cover letter and CV to sam.goetschalckx@professionals.randstad.be or call +32 2 472 73 61

Knowledge

• Familiar with cGMP (Current Good Manufacturing Practices) and ICH (International Conference of Harmonisation) – regulation 
• Strong analytical thinking and negotiation skills, accurate reporting 
• Excellent verbal and written communication and negotiation skills; capable to interact with suppliers and internal organisation

Degree

Bachelor / Master of Science

Languages

Fluent English and Dutch (written and oral)

System knowledge:

• MS Office applications 
• SAP 
• Trackwise 
• TruVault 
• eICD 
• Sharepoint 
• Compliance Wire

As an answer to your high performance & flexibility, Randstad Professionals offers you an interesting salary package, with some interesting extras like:

• Meal vouchers of €7
• Net representation cost of €80
• Hospitalization insurance
• Car + unlimited fuel card OR home-work compensation
• 32 holidays
• End-of-year bonus
• Pension plan
• ECO vouchers
• Opportunities to follow trainings

We offer permanent, project and freelance contracts

And on top of this you'll improve your skills and become an even bigger expert!