Quality Associate

Quality Associate

Location: Beerse

Working mode: Hybrid, 3 days on-site and 2 days working from home

Duration: Until the end of 2024 (opportunity for a contract extension)

Hours: 40 hours per week

Language requirements: Dutch and English

Pay rate range: Competitive hourly rate

Imagine your next project as Quality Associate. Quality Associate ensuring 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 J&J policies, enterprise standards and government-issued environmental, health, safety, quality and regulatory policies and guidelines. Represents the JNJ credo and quality values in contact with the suppliers and will comply with the JNJ regulations for ethic and business conduct in order to strengthen the reputation of J&J.

This position requires the ability of building collaboration and teamwork across the local and global JSC organization, and it interfaces JSC SQ with the quality unit of suppliers.

This position acts as a supporting role.

roles and responsibilities

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

how to succeed

• 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

• Bachelor / Master of Science

• Fluent English / Dutch (written and oral)

systems:

• MS Office applications

• SAP

• Trackwise

• TruVault

• eICD

• Sharepoint

• Compliance Wire

benefits

This role offers a very competitive hourly rate. This contract will run until the end of 2024 and has a strong chance of extension. 

you are welcome here

Johnson & Johnson Innovate Medicine is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

about Johnson & Johnson Innovative Medicine

Patients inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science and compassion, we confidently address some of the most complex diseases of our time and unlock the potential medicines of tomorrow.

Our diverse portfolio spans multiple therapeutic areas — Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension, and Retina.

We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way.

Janssen UK: https://www.janssen.com/uk/

Janssen Ireland: https://www.janssen.com/ireland/

application process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email. The pay rate for this role will depend on how you are paid. Options are available. 

questions

If you would like some additional information about the role please contact: sara.marsalo@randstadsourceright.co.uk (please note that we do not accept applications via email).

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.