Octapharma Pharmazeutika Produktionsges.m.b.H.
Group Expert Analytical Specialist - Quality Control(m/w/x)
Full-timeOn-siteExperienced
Wien
from 4,270.14 / month
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TATakeda Manufacturing Austria AG
Enterprise Quality Auditing Auditor (Senior Manager)(m/w/x)
Wien
Full-timeOn-siteManagement
Nejo AI Summary
Leading GxP quality audits for biopharmaceutical products at a global biopharma. Six years pharmaceutical quality experience and 50% international travel required. Focus on life-improving medicines for complex diseases.
Requirements
- Willingness for 50% international travel
- Scientific degree or equivalent qualification
- Six years' experience in pharmaceutical quality
- Four years leading quality audits
- Knowledge of pharmaceutical quality systems
- Understanding of local and global regulations
- Ability to analyze complex processes
- Strong problem-solving and risk management
- Experience in GxP or QMS
- Competence in leading single-discipline audits
- Experience working in international teams
- Fluent 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
Work Experience
- 6 years
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 Manufacturing Austria 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 Manufacturing Austria AG
Enterprise Quality Auditing Auditor (Senior Manager)(m/w/x)
Wien
Full-timeOn-siteManagement
Nejo AI Summary
Leading GxP quality audits for biopharmaceutical products at a global biopharma. Six years pharmaceutical quality experience and 50% international travel required. Focus on life-improving medicines for complex diseases.
Requirements
- Willingness for 50% international travel
- Scientific degree or equivalent qualification
- Six years' experience in pharmaceutical quality
- Four years leading quality audits
- Knowledge of pharmaceutical quality systems
- Understanding of local and global regulations
- Ability to analyze complex processes
- Strong problem-solving and risk management
- Experience in GxP or QMS
- Competence in leading single-discipline audits
- Experience working in international teams
- Fluent 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
Work Experience
- 6 years
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 Manufacturing Austria 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 Manufacturing Austria AG
Industry
Pharmaceuticals
Description
Das Unternehmen ist ein weltweit führendes, forschendes biopharmazeutisches Unternehmen, das lebensverbessernde Arzneimittel für komplexe Erkrankungen entwickelt.
Not a perfect match?
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