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QA Associate

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Job Description


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 :
    o These are free of error,
    o These are compliant with GMP and internal requirements
    o 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
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

Primary Location
Belgium-Hainaut-La Louvière-
Organization
Janssen Pharmaceutica N.V. (7555)
Job Function
Quality Assurance
Requisition ID
1905786667W