Based in Brussels/Nivelles/Gosselies you will join a collaborative team full of passionate change-maker.
Your mission: you will ensure the quality, safety, and efficacy of products through the performance of internal and external audits of group activities and third parties delivering materials and services.
By performing audits, the function contributes to the compliance with applicable regulations, and where appropriate, internal procedures, quality assurance agreements and other reference documents.
Overall, you will be accountable for independent oversight and reporting on the GxP compliance status of pharmaceutical regulated activities.
- You will prepare, conduct and document on-site/remote/paper-based GxP audits, issues reports, you will also approve CAPA plans and ensure implementation monitoring in cooperation with relevant internal stakeholders
- You will be involved and perform risk assessments and you will keep informed all relevant stakeholders of critical findings resulting from audits.
- You will participate in due diligence of new third parties/projects in quality-related concerns.
- You will support the internal QA teams with the preparation of major client audits and health authority inspections and will perform audit readiness.
- You will support Procurement, Supply Chain, and relevant QA teams with the introduction of new suppliers/contractors/partners.
- You will drive continuous quality and compliance improvement mindset at the group and subsidiary level and third parties, such to ensure compliance with cGMPs.
- You will provide adequate QA/QMS reporting on the audit-related activities.
- You will promote and ensure the application of the company’s values and will act as the company’s representative by showing respect and being an ambassador for it.
REQUIREMENTS / QUALIFICATIONS
- Master’s degree in life sciences-related field.
- Minimum 5 years of relevant experience in auditing in the biopharmaceutical industry, with a minimum of 30 audits performed as lead auditor.
- Certified auditor is desirable.
- Strong working knowledge of cGMPs covering worldwide territories (at least USA and EU) and international organizations (WHO).
- Experience preparing technical/complex written materials that are accurate, clear, logical, well organized.
- Excellent English, both written and spoken (native level is an asset)
- Excellent interpersonal written and oral communication skills
- Independent and Self-organized
- Ability to travel worldwide, also on short notice.