Distribution Quality Partner
Contracting – Walloon Brabant
What are your responsibilities?
- Operational Quality Support
- Ensure cGMP/GDP and related regulatory requirements are successfully implemented and maintained within internal quality system.
- Review and approve investigations, deviations, change controls, complaints, procedures or other process-related documents
- Vendor Quality Management
- Support GDP vendor management activities – periodic performance oversight, and resolution of quality issues, including writing and reviewing Quality Agreement.
- Expert GDP Oversight
- Act as an experienced SME for GDP matters within the team, supporting the team with interpretation of regulations.
- Continuous Improvement
- Identify opportunities to optimize distribution Quality processes and ways of working; propose and implement improvements to increase efficiency and inspection readiness of GDP activities.
Who are you?
- A minimum of 5-8 years of experience in the pharmaceutical industry, previous experience in Quality in GDP
- Deep understanding of EU GDP Guidelines (2013/C 343/01) and relevant cGMP concepts.
- Strong knowledge of global distribution models (3PL, carriers, warehouses, temperature-controlled distribution).
- Previous experience as Responsible Person is an asset
- Ability to support daily Quality decisions (go/no-go for shipments, deviation triage, documentation review, write and review quality agreement).
- Take ownership of topics and drive them to closure.
- Analytical mind-set and very good organizational skills
- Fluent in English