Swedish Orphan Biovitrum AGSwitzerland
Date de publication:10 août 2022
Type de contrat:Durée indéterminée
Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere.
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.
- 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.
- 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.
• 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 abilitiesIn addition, you must demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership.
The position will be based in Basel, Switzerland.
Recruitment contact & how to apply
If you are interested in applying for this position, please submit your CV and cover letter through the apply button above.
Sobi is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, disability, age, sexual orientation, gender identity, or national origin. Sobi is committed to providing access, equal opportunity and reasonable accommodation for individuals with disabilities in employment, its services, programs and activities.
30 Oct, 2022