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Lead Auditor
vor 2 Wochen
For our location in St.Gallen, we are currently looking for a
**LEAD AUDITOR**:
**RESPONSIBILITIES**:
- organize and perform GMP-/ GDP external / internal audits and self-inspection as lead auditor
- reflect regulatory standards on audit management process and thirdparty management process
- perform third party vendor qualification processes and performance reviews
- manage audit related CAPAs according to global/local standards
- ensure that all audit records are updated and maintained in time
- support Health Authority inspections and customer audits according to Regulatory standards and internal procedures
- support qualification of GMP-/ GDP-auditors (training, Trackwise access)
- support completion of received Third Party Mail-audits / Questionnaires
**KEY MEASURES OF SUCCESS**:
- Assurance for conformity to internal policies and standards
- Manage Planning, Execution and Management of GXP audit programs
- Successful collaboration with all stakeholders within and outside Quality Management
- Support internal stakeholders (GMP, GDP) with audit related quality and compliance
- Ensure GXP Inspection readiness
**QUALIFICATIONS**:
- Degree/masters in Natural Sciences
- Auditing experience for GMP
- Minimum of 8 years overall experience within the pharmaceutical, biotechnology, or medical device industry
- At least 5 years ‘experience in Quality Assurance role, including global and/or regional audit responsibility
- Lean six sigma/Operational excellence qualification/experience
- Experience of managing/interacting with global stakeholders
- Strong language and communication skills (German/English)
CSL Vifor is committed to provide equal employment opportunity for all.
**About CSL Vifor**:
CSL Vifor aims to become the global leader in iron deficiency and nephrology.
The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions across iron, dialysis, nephrology and rare conditions. CSL Vifor strives to help patients around the world with severe, chronic and rare diseases lead better, healthier lives. It specializes in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision patient care.
**We want CSL to reflect the world around us**:
As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
**Do work that matters at CSL Vifor**:
