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Defining validation strategies for NPI, TT, and process changes in Life Science and Healthcare. Process validation experience required. On-site coordination, training production teams.
Requirements
- Master of Science in Biotechnology, Life Sciences, or (Bio)Chemistry or equivalent degree, or at least 5 years of professional experience in biotechnology
- Demonstrated experience in process validation
- Strong experience in Drug Substance processes (asset)
- Strong analytical and synthesis capabilities
- Excellent writing skills
- Proficiency with GMP/GDP
- Good knowledge of health authority requirements
- Organization, persistence, and resilience
- Collaborative mindset and teamwork skills
- Ability to work independently and autonomously
- Very good communication skills
- Aptitude for digital tools
- Interest in statistical analyses
- Fluent French (spoken and written)
- Fluent English (spoken and written)
Tasks
- Define validation strategies for NPI, TT, and process changes
- Identify risks and optimize technical choices
- Coordinate on-site process validation activities
- Prepare required validation documents
- Train production teams on validation protocols
- Supervise execution of validation protocols
- Manage documentation and data using quality systems
- Collect and compile production data
- Interpret validation test results
- Manage deviations and validation investigations
- Update validation procedures and standards
- Promote integrity and professional ethics
- Ensure compliance with legal and regulatory directives
Work Experience
- 5 years
Education
- Master's degree
Languages
- French – Fluent
- English – Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of SUSONITY 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.
Defining validation strategies for NPI, TT, and process changes in Life Science and Healthcare. Process validation experience required. On-site coordination, training production teams.
Requirements
- Master of Science in Biotechnology, Life Sciences, or (Bio)Chemistry or equivalent degree, or at least 5 years of professional experience in biotechnology
- Demonstrated experience in process validation
- Strong experience in Drug Substance processes (asset)
- Strong analytical and synthesis capabilities
- Excellent writing skills
- Proficiency with GMP/GDP
- Good knowledge of health authority requirements
- Organization, persistence, and resilience
- Collaborative mindset and teamwork skills
- Ability to work independently and autonomously
- Very good communication skills
- Aptitude for digital tools
- Interest in statistical analyses
- Fluent French (spoken and written)
- Fluent English (spoken and written)
Tasks
- Define validation strategies for NPI, TT, and process changes
- Identify risks and optimize technical choices
- Coordinate on-site process validation activities
- Prepare required validation documents
- Train production teams on validation protocols
- Supervise execution of validation protocols
- Manage documentation and data using quality systems
- Collect and compile production data
- Interpret validation test results
- Manage deviations and validation investigations
- Update validation procedures and standards
- Promote integrity and professional ethics
- Ensure compliance with legal and regulatory directives
Work Experience
- 5 years
Education
- Master's degree
Languages
- French – Fluent
- English – Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of SUSONITY 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
SUSONITY
Industry
Healthcare
Description
Das Unternehmen entwickelt Medikamente, intelligente Geräte und innovative Technologien in Therapiegebieten wie der Onkologie, Neurologie und Fruchtbarkeit.