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Johnson & Johnson Carrières

QA Associate

La Louvière, Belgique
Quality Assurance


Description du poste

Requisition ID: 1805706092W

General Mission
               
  • 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.
                                               
Specific Missions       
 

Operational activities and Quality System Management

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

Returned products

 
  • Collaborate with Operations and Customer Service for disposition on products
returned from customers.
 
Q-shipment
 
  • 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.

 
Improvement
 
  • 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.
 
Project
 
  • 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).
 

Supplier Management

 
  • Coordinate the supplier management activities (including suppliers approval
and maintenance of compliant state).
 

Repack activities

 
  • 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
version management


Qualifications
Profile needed for this function
 
Knowledge
 
  • Current Good Manufacturing, Documentation & Distribution practices.
  • QA related experience within an operational pharmaceutical environment.
 
Degree
 
  • Master degree
 
Languages
 
  • French
  • English
 
Specific know how of systems
  • SAP
  • -Trackwise
  • -Docspace
  • -Compliance wire
  • Microsoft Office applications


Emplacement principal
Belgique-Hainaut-La Louvière-
Organisation
Janssen Pharmaceutica N.V. (7555)
Fonction
Quality Assurance
Requisition ID
1805706092W