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Quality Systems Specialist - Documentation(m/w/x)
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
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Quality Systems Specialist - Documentation(m/w/x)
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
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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