Locations: La Louvière, Belgium
Functions: Quality Assurance
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Requisition ID: 1805706092W
* Ensure and support Operations of European Distribution Center (DC La Louvière) in Good Distribution and Manufacturing Practices in the warehouse and in the repackaging department.
* Assist the Site Quality Head in implementing and maintaining Quality System in the European Distribution Center (DC La Louvière).
* 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).
* Work in line with Credo Values, Janssen Supply Chain and J&J CLS Requirements.
* Work in line with the Safety, Health and Environmental principles.
* Participate to the process improvement as process owner.
Operational activities and Quality System Management
* Write, review and/or approve Work Instructions (WI) and Procedures (SOP)
* Collaborate with other departments for documentation content and ensure
* Good Documentation Practices are followed.
* Act as delegate of the Responsible Person for the review and approval of activities
* listed in DS-FRM-36468 (Responsible Person activities delegation list).
Non- conformities & Complaints:
* Initiate, investigate and/or approve Quality Issues, Correctives and Preventives
* actions and complaints related to distribution activities and repackaging activities.
* Initiate, assess and/or approve Change Controls related to distribution activities and
* repackaging activities.
* Collaborate with Operations and Customer Service for disposition on products
returned from customers.
* Prepare/approve the required documents to establish shipments under quarantine
(i.e : before the final QP release of the products).
Audits & inspections
* Support and actively participate to quality internal/external audits and check rounds.
This include audits preparation, audits completion and audits follow-up.
* Provide data/information for the Quality Improvement Plan (QIP)
* and Quality Management Review (QMR) meetings
* Review and improve processes of the QMS, ensure that KPIs are in place.
* Participate to the processes improvement as process owner.
QA on the floor
* Support operations to work in compliance with GMP and GDP rules.
Training & Qualification
* Deliver GMP/GDP training to warehouse and repackaging personnel
to ensure operational personnel has an appropriate understanding of the GMP/GDP.
* Review training curricula and create training materials (where applicable).
Recall & Destruction
* Coordinate the recall and destruction processes.
* Participate in the development of projects implementation in collaboration with Operations.
Qualification & Validation
* Coordinate the validation, calibration and qualification of equipment.
* Follow-up activities related to facilities with potential quality impact on products
(pest control, temperature monitoring).
* Coordinate the supplier management activities (including suppliers approval
and maintenance of compliant state).
* Act as Quality Assurance representative within the Repack team.
* Review and approve GMP documentation, including Batch records, related to
repack activities of finished products to ensure that :
* These are free of error,
* These are compliant with GMP and internal requirements
* Material and printed components are compliant prior use.
Batch/products disposition activities
* Assess and change the batch status (product disposition) of customer returns
and repacked products, as per DS-FRM-36468 (RP activities delegation list).
* Change the batch status in order to establish shipments under quarantine
(before the final QP release of the products),as per DS-FRM-36468.
* Act as back-up for EDN QA team, for any other batch disposition activities and
Profile needed for this function
* Current Good Manufacturing, Documentation & Distribution practices.
* QA related experience within an operational pharmaceutical environment.
* Master degree
Specific know how of systems
* -Compliance wire
* Microsoft Office applications
Janssen Pharmaceutica N.V. (7555)