For an international pharmaceutical company located in Wavre.
In the team Analytical method Remediation, the manager has the accountability of the Testing Quality Review process. This process allows identification of methods at risk for the business and ensures that action plan is defined and execute according to CQC priorities.
• Lead the Testing quality review process:
o accountable for the scoring of CQC methods,
o accountable and responsible of report generation
o accountable that the CQC has an approved remediation plan for methods at risk.
• Accountable for the in use status of the project by tracking process progress, following specific KPI and reporting to the defined governance.
• Coordinate and facilitate the initial evaluation of high and medium risk methods.
• Coordinate and lead investigation of significant analytical and quality issues in order to guarantee the continuity of supply and in accordance with the current regulations
• Continuous improvement of this new process and tools used for the scoring
• Ph.D. in Analytical Chemistry, Biochemistry, or related field
• Ideally Green Belt certified
• At least 5 years of experience in pharmaceutical industry is an asset
• Experience in biochemical, biological and/or physico-chemical assay
• Good Knowledge in cGMP
• Experience in project management and change management
• Demonstrated ability to work in multi-disciplinary teams, displaying excellent interpersonal, organizational, and communication skill
• Good communication skills towards internal clients (commercial teams, product coordinators, QA, RA, ...)
• Autonomous and proactive
• Scientific and documentary rigor
• Able to manage several project simultaneously
• Able to interact with several internal clients simultaneously
• English written & spoken
• Good Knowledge of Microsoft Office (mainly Excel and MS project)
+32 (0)10 807 115