Gxp Auditor
vor 4 Stunden
**GxP Auditor**
**Role & Function**
The purpose of the position is to perform GxP Audits (GMP, GDP, GCP, GVP) and contribute to develop and maintain the global Sobi GxP 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.This position will be based in Switzerland, Sweden or other countries in Europe.
**Key Responsibilities**
- Support the strategic development of an effective global risk-based audit strategy (internal & external) and program. Collect, collate, and incorporate input into the audit strategy and plan.
- Plan, lead, conduct, document, and follow-up of GxP audit as Lead Auditor or Co Auditor ( internal audits/self-inspections within Sobi’s QMS as well as external audits of Sobi’s CMOs, suppliers and service providers) according to the requirements specified in the respective Sobi procedures (as well as applicable regulations, standards, quality agreements, and guidance documents) working ins strong collaboration with the GxP Audit coordinator and relevant stakeholders.
- Provide regulatory guidance for timely remediation and recommendations regarding acceptability of the proposed filing
- Ensure appropriate escalation to responsible management in case of critical findings and support immediate 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 GxP Audit coordinator and other stakeholder QA representative and Auditee.
- Prepare regular status report on performed GxP audits, audit trending and agreed upon metrics to ensure oversight.
- Support Authority inspections and partner audits
- Maintain knowledge of company policies, SOPs, and supporting documents related to drug
- development/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 GxP audits including supporting documents
- Act as GxP compliance consultant for GxP trainings, task forces, continuous improvement projects as needed.
**Qualifications**
- University degree in Life Sciences or related discipline.
- At least 10 years’ experience from the pharmaceutical industry with GMP/GDP responsibilities.
- Experience of working with GxP audits/inspections.
**Personal attributes**
- Excellent knowhow of the EU/US/RoW regulations within GxP
- Excellent verbal and written communication skills
- Excellent knowledge in document handling in computerised systems
- Delivery focus
- Collaborative
- Structured and detail oriented
- Strong individual initiative, organizational/people skills and multi-tasking abilities
**Location**
The position will be based in Switzerland.
**Benefits**:
- Company pension
- Company phone
- Long-term profit-sharing plan
- Work from home
Schedule:
- Monday to Friday
Supplemental Pay:
- Performance bonus
**Experience**:
- pharmaceutical industry with GMP/GDP responsibilities: 10 years (preferred)
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