Sr GMP GDP Auditor

The purpose of the position is to perform GMP GDP Audits (GMP, GDP,) and contribute to develop and maintain the global Sobi GMP GDP audit strategy and audit program(s). The audits will be both internal audits/self-inspections within Sobi’s QMS as well as external audits of Sobi’s CMOs, suppliers and service providers. The employee will also have the main responsibility for the administration of audits and audit programs and plannings in the computerised systems at Sobi. Key Responsibilities - Drive strategic development of an effective global risk-based audit strategy (internal & external) andprogram. Collect, collate, and incorporate input into the audit strategy and plan.- Plan, lead, conduct, document, and follow-up of internal and external GMP GDP audits (Primarilydedicated to GMP/GDP) as Lead Auditor or Co Auditor of Sobi’s CMOs, suppliers and service providers)according to the requirements specified in the respective Sobi procedures (as well as applicableregulations, standards, quality agreements, and guidance documents) working ins strong collaborationwith the GMP GDP Audit coordinator and relevant stakeholders.- Lead Auditor or Co Auditor of internal audits/self-inspections within Sobi’s QMS as well as- Provide regulatory guidance for timely remediation and recommendations regarding acceptability of theproposed filing- Ensure appropriate escalation to responsible management in case of critical findings and supportimmediate follow-up. Ensure adequate definition and recording of mitigation plans when applicable.- Assess the adequacy of responses (CAPA plans) to audit findings in cooperation with the GMP GDP Auditcoordinator and other stakeholder QA representative and Auditee.- Prepare regular status report on performed GMP GDP audits (Primarily dedicated to GMP/GDP), audittrending and agreed upon metrics to ensure oversight.- Support Authority inspections and partner audits- Maintain knowledge of company policies, SOPs, and supporting documents related to drugdevelopment/manufacturing/distribution as well as FDA and EU regulations and ICH guidance documents(as applicable) along with any other national or international regulations- SOP Author for SOPs related to GMP GDP audits including supporting documents Act as GMP GDPcompliance consultant for GMP GDP trainings, task forces, continuous improvement projects as needed.- Act as GMP GDP compliance consultant for GMP GDP trainings, task forces, continuous improvement projects as needed.