Ext Quality Mgt & Supplier Compliance Specialist

Required Qualifications

• Technical University Degree (health, pharma, technical, chemical areas are advantage)
• 4 to 8 years industry experience specifically in GxP with a strong exposure to Supplier qualification, Third Party Management, Supplier auditing, Quality Agreements, GMP compliance, Risk assessment methodologies & Outsourced activity management.
• Experience performing or supporting supplier audits and paper assessments.
• Strong understanding of supplier qualification processes, supplier risk management and CAPA management.
• Good knowledge of GMP, GDP, quality systems and Health Authority expectations.
• Strong analytical, problem-solving and risk-based decision-making skills.
• Ability to operate effectively in a cross-functional, matrix environment.
• Strong written and verbal communication skills in English.
• Experience with Quality Forward, eQMS systems, supplier quality databases and audit management tools is highly desirable.
• Self-awareness, willingness to further develop own strengths and explore opportunities for improvement.

Main Accountabilities and Duties

• Third Party Lifecycle Management: Create and maintain Third Party records in Quality Forward.
• Initiate and manage TP lifecycle change controls.
• Support supplier onboarding, qualification, updates, suspensions and discontinuations.
• Maintain supplier qualification documentation and records.
• Ensure completeness, accuracy and traceability of TP records.

• Audit Coordination & Assessments: Create and coordinate supplier audit requests.
• Execute paper assessments and desktop supplier evaluations.
• Support planning, scheduling and coordination of supplier audits.
• Maintain audit documentation and records.
• Support closure of audit observations and actions.

• Quality Agreement Management: Prepare, revise and maintain Quality Technical Agreements (QTAs).

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