PricewaterhouseCoopers AG
Director in Life Sciences Quality Management(m/w/x)
Full-timeOn-siteManagement
Zürich
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TATakeda Pharmaceuticals International AG
Enterprise Quality Auditing Auditor (Senior Manager)(m/w/x)
Zürich
Full-timeOn-siteSenior
Nejo AI Summary
Leading GxP quality audits for novel specialty pharmaceuticals and patient support programs. Six years GxP experience and four years leading quality audits required. Direct impact on patient care transformation.
Requirements
- Scientific degree or equivalent qualification
- Six years' experience in GxP
- Four years leading quality audits
- Knowledge of pharmaceutical quality systems
- Understanding of local and global regulations
- Ability to analyze complex processes
- Strong risk management and problem-solving
- Experience in GDP or manufacturing processes
- Competence in leading single-discipline audits
- Experience working in international teams
- Fluency in written and spoken English
- Proficiency with current digital tools
Tasks
- Lead the planning and execution of GxP quality audits
- Perform risk-based audit preparation and data mining
- Develop audit agendas and document performance observations
- Monitor and improve PV and Medical system audit metrics
- Assess risks and evaluate corrective action responses
- Approve audit reports and official records
- Manage self-inspections and resolve resulting CAPAs
- Support inspection readiness and due diligence activities
- Collaborate with R&D and Pharmacovigilance on supplier audits
- Drive continuous improvement for quality auditing processes
- Participate in Communities of Practice and risk assessments
- Train lead auditors on procedures and policies
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- Quality Management Systems (QMS)
- Digital tools
Benefits
Diverse Work
- Stimulating careers
Informal Culture
- Inclusive, collaborative workplace
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Takeda Pharmaceuticals International AG and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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TATakeda Pharmaceuticals International AG
Enterprise Quality Auditing Auditor (Senior Manager)(m/w/x)
Zürich
Full-timeOn-siteSenior
Nejo AI Summary
Leading GxP quality audits for novel specialty pharmaceuticals and patient support programs. Six years GxP experience and four years leading quality audits required. Direct impact on patient care transformation.
Requirements
- Scientific degree or equivalent qualification
- Six years' experience in GxP
- Four years leading quality audits
- Knowledge of pharmaceutical quality systems
- Understanding of local and global regulations
- Ability to analyze complex processes
- Strong risk management and problem-solving
- Experience in GDP or manufacturing processes
- Competence in leading single-discipline audits
- Experience working in international teams
- Fluency in written and spoken English
- Proficiency with current digital tools
Tasks
- Lead the planning and execution of GxP quality audits
- Perform risk-based audit preparation and data mining
- Develop audit agendas and document performance observations
- Monitor and improve PV and Medical system audit metrics
- Assess risks and evaluate corrective action responses
- Approve audit reports and official records
- Manage self-inspections and resolve resulting CAPAs
- Support inspection readiness and due diligence activities
- Collaborate with R&D and Pharmacovigilance on supplier audits
- Drive continuous improvement for quality auditing processes
- Participate in Communities of Practice and risk assessments
- Train lead auditors on procedures and policies
Education
- Bachelor's degree
Languages
- English – Business Fluent
Tools & Technologies
- Quality Management Systems (QMS)
- Digital tools
Benefits
Diverse Work
- Stimulating careers
Informal Culture
- Inclusive, collaborative workplace
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Takeda Pharmaceuticals International AG and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
Takeda Pharmaceuticals International AG
Industry
Pharmaceuticals
Description
The company is transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs.
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