Descrizione dell'offerta
Experteer Overview
In this role you will perform international GMP/GxP supplier and contractor audits to uphold quality across the end-to-end supply chain. You will work with cross-functional teams to qualify suppliers, draft quality agreements, and ensure compliance with GMP, GDP and ISO standards. The role supports ongoing supplier qualification, monitoring, and corrective actions across global partners. You’ll contribute to a culture of reliability and ethical quality while collaborating with global sites and external CMOs. Responsibilities
Plan, execute and lead on-site GMP/GxP audits across Europe and worldwide; prepare agendas, write English audit reports, and contribute to annual audit plans. Draft and maintain quality agreements and GxP-related procedures, templates, and user guides. Manage supplier qualification, validation, and change control impacts related to suppliers and GxP services. Monitor supplier quality performance, track corrective actions, and verify effectiveness. Collaborate in investigations of non-conformities and drive CAPAs with suppliers and internal stakeholders. Maintain up-to-date supplier quality statements and support regulatory product statements for dossiers. Conduct supplier validation activities for raw materials and packaging materials; produce validation reports. Evaluate and score suppliers and external contractors to determine reliability and risk. Qualifications
Minimum 5 years of hands-on GMP Auditor experience (lead or active co-auditor). Proven experience in supplier/contractor audits. Strong knowledge of GMP (EU & FDA), GDP and/or ISO standards. Degree in scientific disciplines (Pharmacy, CTF, Biology, Chemistry, etc.). 5 years of auditing experience with sterile, biological products. Good spoken and written English. Benefits
Comprehensive healthcare programs. Work-life balance initiatives. Relocation support. Competitive salary and bonuses. Flexible working arrangements. Remote work options.
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In this role you will perform international GMP/GxP supplier and contractor audits to uphold quality across the end-to-end supply chain. You will work with cross-functional teams to qualify suppliers, draft quality agreements, and ensure compliance with GMP, GDP and ISO standards. The role supports ongoing supplier qualification, monitoring, and corrective actions across global partners. You’ll contribute to a culture of reliability and ethical quality while collaborating with global sites and external CMOs. Responsibilities
Plan, execute and lead on-site GMP/GxP audits across Europe and worldwide; prepare agendas, write English audit reports, and contribute to annual audit plans. Draft and maintain quality agreements and GxP-related procedures, templates, and user guides. Manage supplier qualification, validation, and change control impacts related to suppliers and GxP services. Monitor supplier quality performance, track corrective actions, and verify effectiveness. Collaborate in investigations of non-conformities and drive CAPAs with suppliers and internal stakeholders. Maintain up-to-date supplier quality statements and support regulatory product statements for dossiers. Conduct supplier validation activities for raw materials and packaging materials; produce validation reports. Evaluate and score suppliers and external contractors to determine reliability and risk. Qualifications
Minimum 5 years of hands-on GMP Auditor experience (lead or active co-auditor). Proven experience in supplier/contractor audits. Strong knowledge of GMP (EU & FDA), GDP and/or ISO standards. Degree in scientific disciplines (Pharmacy, CTF, Biology, Chemistry, etc.). 5 years of auditing experience with sterile, biological products. Good spoken and written English. Benefits
Comprehensive healthcare programs. Work-life balance initiatives. Relocation support. Competitive salary and bonuses. Flexible working arrangements. Remote work options.
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Candidatura e Ritorno (in fondo)
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