Job Title : 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 workplace.
- 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.
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