HireDiversity

La Louvière, BE

Senior Quality Assurance Manager European Distribution Center-000009N2

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.

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

The function holder is the overall quality responsible for all operational activities within the EDC. The function holder is responsible for the on time delivery of products in compliance with GDP.

You will be responsible for following:

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Act as delegate 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. The delegate QP will release products which are manufactured outside EEA and stored in the European Distribution Center. These activities will be performed under the responsibility of the Qualified Person of Janssen Pharmaceutica NV.

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Assure all deviations related to distribution activities (ex. temperature excursions), warehouse activities (ex. damages) and repackaging activities are thoroughly investigated. The investigations, including corrective and preventive actions and impact assessments of the products, needs to be documented in the Trackwise deviation handling system. Critical deviations/CAPA will be escalated to the Qualified Person of Janssen Pharmaceutica NV, according to the applicable escalation procedure.

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Guarantee all customer complaints related to distribution and repackaging activities are investigated. 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. Critical complaints will be escalated to the Qualified Person of Janssen Pharmaceutica NV, according to the applicable escalation procedure.

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Ensure all customer returns, which require quality involvement, are handled in a timely manner. 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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Review and approve changes related to management of the Sodiac project and to other activities in the EDC. These changes will be documented in the Trackwise COC system. Critical changes will be escalated to the Qualified Person of Janssen Pharmaceutica NV, according to the applicable escalation procedure.

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Perform Quality Improvement Plan (QIP) meetings, where trends on 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. The QIP report will be shared with the Qualified Person of Janssen Pharmaceutica NV, in order to assure the quality oversight of the QP.

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Perform Quality Management Review meetings on a quarterly basis, including a business overview, review of HA actions and a total quality management system review to evaluate if additional actions are required based upon the trends observed.

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Assure check rounds and internal audits in the warehouse and repackaging department are performed according to the approved plan. 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. The internal audit plan and the related internal audit reports will be shared with the Qualified Person of Janssen Pharmaceutica NV, in order to assure the quality oversight of the QP.

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Review and approve quality related procedures to 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 to 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. To ensure the repackaging activities will be performed consistently according to the cGMP regulations. Assure batch record review are performed after finalization of the repackaging activities to assure the visual control activities are performed in accordance to the cGMP regulations.

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Assure Quality Agreements with all involved partners of the European Distribution Center remain up to date.

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Assure the quality organization and the operational organization of the European Distribution Center (including CEVA personnel) are ready for inspections. Lead, support and follow up of internal and external inspections.

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Support improvement project within the European Distribution Center and prepare the organization to take up new responsibilities as a result of other projects (Sodiac, Medical Devices).

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Ensure communication to the Qualified Person of Janssen Pharmaceutica NV (Beerse). Active participation in the quality meetings of Beerse to continuously improve the quality and compliance level and to align with the Beerse quality processes.

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Ensure communication into the CLS quality EMEA organization. Active participation in the quality meetings of CLS Quality EMEA to continuously improve the quality and compliance level.

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Ensure communication into the CLS European Distribution Network organization. Active participation in the weekly meetings of CLS European Distribution Network to improve the overall customer satisfaction level.

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

Qualifications


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You are a Certified Industrial Pharmacist with at least 5 years experience in pharmaceutical industry.

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You have good knowledge of current Good Manufacturing Practices (GMP), Good Distribution Practices (GDP) and Pharmaceutical legislation and regulations (CFR, ICH, ph.Eur, USP,...).

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You have extensive QA related experience within an operational pharmaceutical environment.

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You speak French as well as English. Dutch is an asset.

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Knowledge of SAP and Office applications is required.

- CBLD-BE

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