Quality Associate

  • Location: MECHELEN
  • Type: Contracting
  • Job #20008

Will you be our new ambassador?

Jefferson Wells Life Sciences specializes in supporting pharma & biotech companies in their daily challenges. Hence our interest in experts like you to pass our team. 

Let's look together at your first challenge with us!

Quality Associate

You will ensure quality standards are achieved and maintained at suppliers through supporting management, and oversight on Quality Operations functions for external business partners. This support includes ensuring continuous compliance with relevant regulatory health authority requirements, effective risk management, strategy development and execution, and effective collaboration between R&D, Operations, Procurement, TechOps, Regulatory Affairs and other technical disciplines (EHS). Functions and activities include quality assurance review and approval functions (such as Change Control, Deviation Handling), audit activities, pro-active Quality Engagement, creation and management of risk mitigation plans for suppliers. Quality Associate supports ensuring business, quality and compliance goals adhere to policies, enterprise standards and government-issued environmental, health, safety, quality and regulatory policies and guidelines. Represents the credo and quality values in contact with the suppliers and will comply with the regulations for ethic and business conduct in order to strengthen the reputation. This position requires the ability of building collaboration and teamwork across the local and global organization, and it interfaces SQ with the quality unit of suppliers. This position acts as a supporting role.

Scope of work:

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

    Profile:
     

  • You are familiar with cGMP (Current Good Manufacturing Practices) and ICH (International Conference of Harmonisation) – regulation
  • You have strong analytical thinking and negotiation skills, accurate reporting
  • You have excellent verbal and written communication and negotiation skills; capable to interact with suppliers and internal organization
  • You have a bachelor/Master of Science
  • You are fluent in English / Dutch (written and oral)
  • You have specific know how of systems
    • MS Office applications
    • SAP
    •  Trackwise
    • TruVault
    •  eICD
    •  SharepointCompliance Wire

 

What can Jefferson Wells do for you?

As an ambassador you have the opportunity to grow within international companies where you can build a strong network. Through a personal follow-up, you receive quality support in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal training and education. 

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