You are on page 1of 1

Quality Assurance Consultant - Senior

La Louviere, Belgium (on-site)


20h/week , 9 months contract
Pay Rate: max. €64 per hour
Max submissions: 3

Responsibilities

 Investigate deviations related to departmental activities. The investigations, including


corrective and preventive actions (CAPAs) and impact assessments of the products, needs to
be documented in the company deviations handling system.
 Assist in change controls and supplier management.
 Follow up customer returns and destruction. Products/services are investigated physically and
impact assessment on quality and compliance is performed, before the products/services can
be taken back for further use.
 Deliver GMP and GDP training to departmental personnel in order to assure operational
personnel has an appropriate understanding of the Good Practices.
 Assist in the routine activities of the department with doc and training administration
 Assist in check rounds and internal audits in the activities of the department. The goal of these
self-inspections is to perform an in-depth review of the operation in view of the applicable
cGMP regulations.
 Review and approve quality related procedures. These procedures assure the day-to-day
activities are performed in accordance with the GxP regulations. Procedures are controlled by
the company document control system.
 Work in close collaboration with Quality Representatives and Quality Representatives of the
company Organizations (Local Operating Companies).
 Assist in the preparations of external and internal inspections related to overall quality and
compliance.
 Review and approve master data related to departmental activities.
 Review and approve the master batch records, based on the approved request for the
departmental activities. These batch records ensure the activities will be performed
consistently according to the cGMP regulations.
 Perform batch record review immediately after finalization of the departmental activities. This
process assures the activities are performed in accordance to the cGMP regulations.
 Work in line with the Safety, Health and Environmental principles.

Requirements

 A relevant degree or similar qualification


 Knowledge in TRACKWISE, DOSPACE and COMPLIANCE WIRE systems would be an asset
 Strong experience in GMP and GDP compliance - able to train others in compliance
 Experience with implementing CAPAs
 Experience in self-inspections and external audits
 Languages: French and English mandatory