Supplier Quality Expert / Auditor
Professional | Permanent | Full-time | Hybrid
Our Corporate Functions teams make sure everything at Grünenthal runs smoothly by bringing together people with a wide range of skills – from experts in finance, IT, HR, law and compliance through to business strategists and creative media minds. If you’re a great collaborator and a strong communicator, you’ll feel right at home here. Join our team and join forces with colleagues across our business to maximise our company’s positive impact on patients and their families.
Position Overview:
Supplier Quality Expert / Auditor plays a critical role in ensuring the quality and compliance of external suppliers across the full lifecycle, from qualification to ongoing performance monitoring.
What the job looks like:
• Audits and Supplier Qualification:
• Support the global audit program by planning, preparing and conducting external suppliers audits, including postal and remote audits
• Generation of audit reports and approval of CAPA plan and managing it on the quality system available
• Follow up of CAPAs resulting from critical findings
• Closure of the audits after approval of CAPA plan
• E2E Overview of the Supplier Quality Lifecycle: TQA, complaints, issues, PQR.
• TQA: stablishing quality contracts with external suppliers
• Complaint: handling material and product complaints in the quality management system
• Contribute to gain quality oversight by monitoring, reporting and escalating supplier performance results
• PQR: review of PQR provided by our external suppliers
• Supplier Change Notification
• Supplier Performance & Development Activities
• Participate in issue resolution and supplier development initiatives
• Convenient point of contact with local receiving functions.
• Act as interface partner with other global and local strategic departments and business units that contribute to the supplier management process (Procurement, Supply Planning, Logistics, IMQ, CQA)
• Interface with supplier management stakeholders
• Contribute to the deployment, maintenance and continuous improvement of the ESQ processes
• Participation to quality relevant projects and other improvement projects, aligned with Strategy and Governance plans
What you'll bring to the table:
• University degree, preferably in Chemistry, Pharmacy or Engineering and have gained relevant practical experience in production or quality control or quality assurance within pharmaceutical industry.
• At least 3 years broad experience in Pharmaceutical Industry.
• Auditing experience, incl. extensive knowledge of international authority regulations (e.g., PICs, ICH, and FDA) including applicable ISO norms. Additional knowledge of R+D requirements are of advantage.
• Knowledge of elements and requirements in Pharmaceutical Quality Systems.
• Project Management skills and a well-structured approach of organizing processes. Result-oriented, reliable and discrete.
• Advanced knowledge of Quality System Applications e.g. SAP, Trackwise, MasterControl.
• Speak and write fluent English. Furthermore, these international tasks involve travelling (around 60%).
• Strong negotiation and communication skills. Calm and organized approach to hectic and conflict situations. Confident and open-minded in interaction with colleagues and external partner; international and intercultural teamwork skills.
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