Takeda
Product Quality Expert(m/w/x)
Full-timeOn-siteExperienced
Neuenburg
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CHCHE - 8262 Baxalta Manufacturing Sarl
Quality Systems Specialist - Documentation(m/w/x)
Neuenburg
Full-timeOn-siteExperienced
Nejo AI Summary
Defining and auditing quality processes for biopharmaceutical products, including product integrity testing. 2+ years in pharma with GMP/regulatory familiarity required. French/English proficiency, Veeva Vault experience a plus.
Requirements
- Proficiency in electronic document management systems (e.g., Veeva Vault)
- French and English proficiency (minimum B2 level)
- Proficiency in Microsoft Office tools (Word, Excel, Power Point, SharePoint)
- Minimum 2 years experience in (bio)pharmaceutical industry, ideally multinational
- Familiarity with GMP and regulatory guidelines (FDA, EMA, ICH)
- Good understanding of GDDP and Data Integrity principles
- Knowledge of document version control, workflows, and archiving
- Awareness of audit and inspection readiness requirements
Tasks
- Define and specify activities, processes, and standards for quality requirements
- Audit and monitor processes and outputs against defined standards
- Conduct product integrity testing for quality compliance
- Report on process deviations and defects
- Apply basic analytical methods and operational processes
- Follow standard operating procedures
- Communicate clearly and simply with your immediate team
Work Experience
- 2 years
Education
- High school diploma
Languages
- French – Business Fluent
- English – Business Fluent
Tools & Technologies
- Veeva Vault
- Microsoft Office
- Word
- Excel
- Power Point
- SharePoint
- GMP
- FDA
- EMA
- ICH
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of CHE - 8262 Baxalta Manufacturing Sarl 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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CHCHE - 8262 Baxalta Manufacturing Sarl
Quality Systems Specialist - Documentation(m/w/x)
Neuenburg
Full-timeOn-siteExperienced
Nejo AI Summary
Defining and auditing quality processes for biopharmaceutical products, including product integrity testing. 2+ years in pharma with GMP/regulatory familiarity required. French/English proficiency, Veeva Vault experience a plus.
Requirements
- Proficiency in electronic document management systems (e.g., Veeva Vault)
- French and English proficiency (minimum B2 level)
- Proficiency in Microsoft Office tools (Word, Excel, Power Point, SharePoint)
- Minimum 2 years experience in (bio)pharmaceutical industry, ideally multinational
- Familiarity with GMP and regulatory guidelines (FDA, EMA, ICH)
- Good understanding of GDDP and Data Integrity principles
- Knowledge of document version control, workflows, and archiving
- Awareness of audit and inspection readiness requirements
Tasks
- Define and specify activities, processes, and standards for quality requirements
- Audit and monitor processes and outputs against defined standards
- Conduct product integrity testing for quality compliance
- Report on process deviations and defects
- Apply basic analytical methods and operational processes
- Follow standard operating procedures
- Communicate clearly and simply with your immediate team
Work Experience
- 2 years
Education
- High school diploma
Languages
- French – Business Fluent
- English – Business Fluent
Tools & Technologies
- Veeva Vault
- Microsoft Office
- Word
- Excel
- Power Point
- SharePoint
- GMP
- FDA
- EMA
- ICH
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of CHE - 8262 Baxalta Manufacturing Sarl 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
CHE - 8262 Baxalta Manufacturing Sarl
Industry
Manufacturing
Description
The company is a leading biopharmaceutical production site committed to transforming patient care through innovative pharmaceuticals.
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