Required skills
- Extractables & Leachables (E&L)
- Study Design
- Risk Assessment
- Analytical Methods
- Chromatography
- Mass Spectrometry
- Data Interpretation
Nice to have:Container Closure SystemsRegulatory AffairsMethod DevelopmentMethod ValidationStability TestingImpurity Profiling
Languages: German
Job description
Support and technical guidance for Extractables & Leachables (E&L) studies in the pharmaceutical industry, including study design, risk assessment, and data evaluation.
Responsibilities
Profile
- Technical support for Extractables & Leachables studies
- Support with planning and study design
- Execution of risk assessments
- Technical review and evaluation of study and analysis results
- Interpretation of identified extractables/leachables and evaluation of results
- Derivation of necessary follow-up actions based on study results
- Review or support with study protocols and final reports
- Consultation on E&L-specific analytical and regulatory questions
- Sound experience in the field of Extractables & Leachables
- Experience with E&L studies for pharmaceutical products and their technical evaluation
- Experience with pharmaceutical products or drug-container/device systems
- Very good understanding of analytical methods, especially chromatography/mass spectrometry
- Ability to interpret analytical results and derive follow-up actions
- Experience with container closure systems / product-contacting materials (advantageous)
- Knowledge of relevant regulatory requirements and guidelines (advantageous)
- Experience with method development/validation and stability/impurity assessments (advantageous)
Project details
- Start: sofort
- Remote: remote
- Location: Remote, Wien, AT, AT
- Languages: German
Source notes
- Exciting role at a renowned life science company
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