Sr GMP GDP Auditor

Sobi

Basel, Switzerland

Job Description

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) and program. 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 (Primarily dedicated 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 applicable regulations, standards, quality agreements, and guidance documents) working ins strong collaboration with 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 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 GMP GDP Audit coordinator and other stakeholder QA representative and Auditee;
Prepare regular status report on performed GMP GDP audits (Primarily dedicated to GMP/GDP), 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 GMP GDP audits including supporting documents Act as GMP GDP compliance 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.

Qualifications

Education/Learning Experience/Work Experience

University degree in Life Sciences or related discipline;
At least 10 years’ experience from the pharmaceutical industry with GMP/GDP responsibilities;
Experience of Lead GMP GDP audits/inspections;
Experience working as GMP GDP Inspector, or Auditor in the field of Biotechnology and Sterile Manufacturing.

Skills/Knowledge/Languages

Excellent knowhow of the EU/US/RoW regulations within GMP GDP;
Excellent verbal and written communication skills;
Excellent knowledge in document handling in computerised systems.

Personal Attributes

Delivery focus;
Collaborative;
Structured and detail oriented;
Strong individual initiative, organizational/people skills and multi-tasking abilities;
Ownership, paternership and sense of urgency.