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Job Function:

Quality

Job Sub Function:

Customer/Commercial Quality

Job Category:

Professional

All Job Posting Locations:

Beerse, Antwerp, Belgium

Job Description:

Within Johnson & Johnson Innovative Medicine, we are recruiting a QA Associate in Beerse DC part of Commercial Quality (CQ) Organization.

CQ has the mission to advocate for Quality to enhance patient and customer experiences, create better quality outcomes, and drive growth. We are continuously adapting and improving our quality processes to provide hope in a box for our patients.

Beerse DC is part of the IM Distribution HUB and is accountable for the distribution of Narcotics, Clinical Supply and advanced therapy (including CAR-T).

In this pivotal role, you will ensure and support DC Beerse in Good Distribution and Manufacturing Practices in the warehouse and in the repackaging department and assist the Site Quality Head in implementing and maintaining the Quality System EDC Beerse. You will be at the heart of a collaborative network, working closely with colleagues in Supply Chain / Clinical / Advanced therapies.

Are you passionate about ensuring the highest standards of quality in distribution? Join our dynamic team in Beerse as a QA Associate.Key Responsibilities:

• Build strong cross-functional partnerships with Quality and Supply partners to ensure timely shipment.

• Act as Process Owner for Quality System Elements (QSE).

• Ensure that deviations are timely and properly investigated and adequate CAPAs are defined for investigations with potential product quality impact. Ensure in-depth investigations by providing technical, quality and compliance expertise.

• Initiate, assess and/or approve Change Controls related to distribution activities and repackaging activities.

• Act as spokesperson during Health Authority audits.

• Continuously challenge the status quo and support the development and implementation of breakthrough innovative initiatives that deliver sustainable improvement in organizational, quality and compliance performance.

• Participate in the development of projects implementation in collaboration with Operations.

Job Qualifications:

• University degree, scientific orientation (pharmaceutical, chemical, or biological sciences).

• Experience in pharmaceutical supply chain and/or Quality Assurance is an asset.

• Demonstrated ability to work independently while staying connected with key stakeholders.

• Operational Quality is an asset.

• Knowledge in GDP, GTP and GMP is an asset.

• Ability to prioritize, perform risk assessment and develop action plans.

• Understands the business implications regarding quality positions and decisions.

Closing date: please apply by Tuesday 17th of March.

Required Skills:

Preferred Skills:

Administrative Support, Compliance Management, Detail-Oriented, Document Management, Execution Focus, Goal Attainment, Human-Centered Design, Internal Controls, Problem Solving, Process Oriented, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Relationship Building, Report Writing