HireDiversity

La Louvière, BE

Quality Assurance Associate European Distribution Center-0000080J

Description

The Sodiac project will deliver a new integrated European Distribution Platform for Janssen EMEA which will be a strategic enabler to provide innovative integrated health care solutions for our patients and stakeholders. After the go live, pharmaceutical products will be timely delivered to the end customers within the European network.

For this new European Distribution Center we are currently looking for a Quality Assurance Associate.

The function holder is responsible to assure Good Distribution Practices in the Warehouse and current Good Manufacturing Practices in the Repackaging department of the European Distribution Center (EDC) in La Louvière. He/She will continuously improve the quality processes and quality systems in the EDC.

You will be responsible for following:

- Investigate deviations related to distribution activities (ex. temperature excursions), warehouse activities (ex. damages) and repackaging activities. The investigations, including corrective and preventive actions and impact assessments of the products, needs to be documented in the Trackwise deviations handling system. Assist the operational personnel to start and handle deviations in a proper way.
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Investigate customer complaints related to distribution and repackaging activities. For each customer complaint a thorough investigation and root cause analysis needs to be performed. These investigations need to be documented in the PQMS complaint handling system.

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Follow up customer returns and destruction. Products are investigated physically and impact assessment on quality and compliance is performed, before the products can be taken back into the sellable stock.

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Prepare products & documents in order to establish shipments under quarantine (before the release of products).

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Assist in the process to generate Certificates of Analysis.

- Deliver GMP/GDP training to warehouse and repackaging unit personnel in order to assure operational personnel has an appropriate understanding of the Good Manufacturing Practices and Good Distribution Practices.
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Assist in the preparation of Quality Improvement Plan (QIP) meetings. During these QIP meetings deviations and complaints are followed up. The overall quality level will increase by continuous analysis of trending and follow up on implementation of related corrective and preventive actions.

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Assist in check rounds in the warehouse and repackaging department. The goal of these self-inspections is to perform an in-depth review of the operation in view of the applicable cGMP and GDP regulations.

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Review and approve quality related procedures. These procedures assure the day-to-day activities are performed in accordance with the cGMP and GDP regulations. Procedures are controlled by the DOCspace document control system.

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Review and approve master data related to distribution activities. These master data assure products are stored according to the required storage conditions and are distributed according to the required transport conditions.

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Review and approve the master batch records, based on the approved request for repackaging. These batch records ensure the repackaging activities will be performed consistently according to the cGMP regulations.

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Perform batch record review immediately after finalization of the repackaging activities. This process assures the repackaging activities are performed in accordance to the cGMP regulations.

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Work in close collaboration with Quality Representatives of Janssen Supply Chain Organization (Beerse, Latina and Schaffhausen) and Quality Representatives of Janssen Commercial Organization (Local Operating Companies).

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Assist in the preparations of external and internal inspections related to overall quality and compliance.

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Work in line with the Safety, Health and Environmental principles.

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After an in depth training period of several months, act as a backup Qualified Person for Janssen Pharmaceutica to ensure the finished pharmaceutical products are repacked and distributed in compliance with the Marketing Authorisation Application (MAA's) and as required by cGMP and J&J policies and global standards. The delegate QP will release pharmaceutical products and will control exceptional quarantine shipments.

Qualifications


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You are an Industrial Pharmacist, preferably a Qualified Industrial Pharmacist

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QA related experience within an operational pharmaceutical environment is an asset

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You are familiar with current Good Manufacturing Practices (GMP), Good Distribution Practices (GDP) and Pharmaceutical legislation and regulations (CFR, ICH, ph.Eur, USP...).

- You speak French as well as English.
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Knowledge of Office applications is required; knowledge of SAP can be an asset.

- CBLD-BE

Primary Location:Europe/Middle East/Africa-Belgium-Hainaut-La Louvière
Organization: Janssen Pharmaceutica N.V. (7555)