Debiopharm
Pharmaceutical Quality (pQM) Specialist(m/w/x)
Full-timeOn-siteExperienced
Lausanne
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SUSUSONITY
Quality Assurance Expert - Qualification & Validation (Q&V)(m/w/x)
Corsier-sur-Vevey
Full-time, Part-timeOn-siteExperienced
Nejo AI Summary
Process and cleaning validation for Oncology, Neurology, and Fertility medicines. Expertise in computerized system validation and risk analysis required. 4-day work week, 6 weeks vacation.
Requirements
- Degree in Life Sciences, Engineering, or related field
- 4-9 years experience in quality assurance
- Expertise in qualification and validation processes
- Experience in GMP-regulated environment
- Solid knowledge in Process Validation
- Knowledge in Equipment Qualification, Raw Material Qualification and Cleaning Validation is a plus
- Strong understanding of GMP guidelines
- Understanding of regulatory compliance requirements
- Analytical mindset
- Experience in risk assessment
- Experience in deviation handling
- Experience in remediation planning
- Excellent organizational skills
- Ability to review and approve technical documents
- Effective communication skills
- Teamwork skills
- French written & spoken
- English written & spoken
Tasks
- Provide QA expertise in process validation and equipment qualification
- Conduct cleaning validation and raw material qualification
- Review and approve computerized system validation protocols and reports
- Elaborate qualification and validation strategies
- Participate in risk analyses and identify gaps
- Propose remediation plans for identified gaps
- Act as a Quality Subject Matter Expert on specific topics
- Support risk assessments and handle deviations
- Review and approve qualification and validation documents
- Review and approve risk assessments and SOPs
- Make quality decisions according to company standards
- Oversee qualification and validation phases from basic design to first use
- Ensure GMP compliance throughout all qualification and validation phases
Work Experience
- 4 - 9 years
Education
- Bachelor's degree
Languages
- French – Business Fluent
- English – Business 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.
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Full-timeOn-siteExperiencedTolochenaz, Lausannefrom CHF 144,000 / year - SMO Medtronic Europe Sàrl
Quality Systems Specialist(m/w/x)
Full-timeOn-siteExperiencedLausannefrom CHF 144,000 / year - SUSONITY
Associate Scientist(m/w/x)
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SUSUSONITY
Quality Assurance Expert - Qualification & Validation (Q&V)(m/w/x)
Corsier-sur-Vevey
Full-time, Part-timeOn-siteExperienced
Nejo AI Summary
Process and cleaning validation for Oncology, Neurology, and Fertility medicines. Expertise in computerized system validation and risk analysis required. 4-day work week, 6 weeks vacation.
Requirements
- Degree in Life Sciences, Engineering, or related field
- 4-9 years experience in quality assurance
- Expertise in qualification and validation processes
- Experience in GMP-regulated environment
- Solid knowledge in Process Validation
- Knowledge in Equipment Qualification, Raw Material Qualification and Cleaning Validation is a plus
- Strong understanding of GMP guidelines
- Understanding of regulatory compliance requirements
- Analytical mindset
- Experience in risk assessment
- Experience in deviation handling
- Experience in remediation planning
- Excellent organizational skills
- Ability to review and approve technical documents
- Effective communication skills
- Teamwork skills
- French written & spoken
- English written & spoken
Tasks
- Provide QA expertise in process validation and equipment qualification
- Conduct cleaning validation and raw material qualification
- Review and approve computerized system validation protocols and reports
- Elaborate qualification and validation strategies
- Participate in risk analyses and identify gaps
- Propose remediation plans for identified gaps
- Act as a Quality Subject Matter Expert on specific topics
- Support risk assessments and handle deviations
- Review and approve qualification and validation documents
- Review and approve risk assessments and SOPs
- Make quality decisions according to company standards
- Oversee qualification and validation phases from basic design to first use
- Ensure GMP compliance throughout all qualification and validation phases
Work Experience
- 4 - 9 years
Education
- Bachelor's degree
Languages
- French – Business Fluent
- English – Business 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.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
SUSONITY
Industry
Healthcare
Description
Das Unternehmen entwickelt Medikamente, intelligente Geräte und innovative Technologien in Therapiegebieten wie der Onkologie, Neurologie und Fruchtbarkeit.
Not a perfect match?
- Debiopharm
Pharmaceutical Quality (pQM) Specialist(m/w/x)
Full-timeOn-siteExperiencedLausanne - SMO Medtronic Europe Sàrl
Quality Systems Specialist(m/w/x)
Full-timeOn-siteExperiencedTolochenaz, Lausannefrom CHF 144,000 / year - SMO Medtronic Europe Sàrl
Quality Systems Specialist(m/w/x)
Full-timeOn-siteExperiencedLausannefrom CHF 144,000 / year - SUSONITY
Associate Scientist(m/w/x)
Full-timeOn-siteExperiencedCorsier-sur-Vevey - Debiopharm
CSV Lead(m/w/x)
Full-timeOn-siteSeniorLausanne