QA Supervisor

XPE is looking for a QA Supervisor in Brabant Wallon

For our client, a leader in the pharmaceutical sector, we are looking for a QA Supervisor.

 

Job Purpose

                    

Take the responsibility for QA in technical activities supporting the production of commercial vaccines (i.e. maintenance, calibration) inside the Business Unit.

Maintain the compliance level of the existing technical quality systems with regulatory and standards.

 

 

Job Factor

·         Take part in the management and follow-up of deviations & change control regarding technical matters

·         Ensure the implementation and follow-up of an internal audit system for technical activities within the Bulk Business Unit.

·         Ensure the implementation & follow-up of preventive and/or corrective actions for deviations & change control managed by members of the Bulk BU.

·         Manage presentation and argumentation of technical matters during regulatory inspections to ensure minimum impact on the organization.

·         Ensure implementation of technical commitments related to the Bulk BU towards authorities and organize the follow-up of these commitments.

·         Keep informed about changes in quality management and requirements

·         Review maintenance & requalification programs for the Bulk BU: ensures the compliance of these programs with procedures, regulatory and GSK standards.

·         Approve technical forms & drawings related to GMP maintenance & requalification activities for Bulk BU.

 

Profile

·         Bio-engineering, engineering or scientific master degree

·         Relevant experience as QA Coordinator in a production environment

·         Experience in the pharmaceutical sector

·         Integrity, empathy, capability to discuss and challenge with respect to compliance, adaptability to changes vs emergency, pedagogic skills

·         English read & spoken

·         Knowledge of pharmaceutical regulations is an asset

·         Knowledge of SAP is an asset

 

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