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Cleaning Validation Expert(m/w/x)
Defining cleaning validation strategies for medicines and devices. MSc in Life Sciences or equivalent, with GMP/GDP knowledge required. On-site coordination and process development.
Requirements
- MSc in Biotechnology, Life Sciences, or (Bio)Chemistry, or equivalent degree
- Demonstrated experience in Cleaning validation
- Strong analytical and synthesis capabilities
- Excellent writing skills
- Proficiency with GMP/GDP and health authority requirements
- Organization, persistence, and resilience
- Collaborative and independent work ability
- Very good communication skills
- Aptitude for digital tools
- Fluent French and English (spoken and written)
Tasks
- Define cleaning validation strategies
- Collaborate with project lead and site departments
- Identify risks and potential optimizations
- Develop cleaning processes as needed
- Coordinate on-site cleaning validations
- Prepare required validation documents
- Train production teams on validation protocols
- Supervise validation protocol execution
- Manage data collection from production
- Interpret validation trial results
- Manage deviations and investigations
- Monitor cleaning processes
- Draft monitoring forms and reports
- Update validation procedures and standards
- Ensure compliance with legal and regulatory requirements
- Participate in a culture of integrity and ethics
Work Experience
- 4 - 9 years
Education
- Master's degree
Languages
- French – Fluent
- English – Fluent
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Cleaning Validation Expert(m/w/x)
Defining cleaning validation strategies for medicines and devices. MSc in Life Sciences or equivalent, with GMP/GDP knowledge required. On-site coordination and process development.
Requirements
- MSc in Biotechnology, Life Sciences, or (Bio)Chemistry, or equivalent degree
- Demonstrated experience in Cleaning validation
- Strong analytical and synthesis capabilities
- Excellent writing skills
- Proficiency with GMP/GDP and health authority requirements
- Organization, persistence, and resilience
- Collaborative and independent work ability
- Very good communication skills
- Aptitude for digital tools
- Fluent French and English (spoken and written)
Tasks
- Define cleaning validation strategies
- Collaborate with project lead and site departments
- Identify risks and potential optimizations
- Develop cleaning processes as needed
- Coordinate on-site cleaning validations
- Prepare required validation documents
- Train production teams on validation protocols
- Supervise validation protocol execution
- Manage data collection from production
- Interpret validation trial results
- Manage deviations and investigations
- Monitor cleaning processes
- Draft monitoring forms and reports
- Update validation procedures and standards
- Ensure compliance with legal and regulatory requirements
- Participate in a culture of integrity and ethics
Work Experience
- 4 - 9 years
Education
- Master's degree
Languages
- French – Fluent
- English – Fluent
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
SUSONITY
Industry
Pharmaceuticals
Description
Das Unternehmen entwickelt Medikamente, intelligente Geräte und innovative Technologien in Therapiegebieten wie der Onkologie, Neurologie und Fruchtbarkeit.
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