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Pharmaceutical Risk Assessment Specialist
3 weeks ago
A skilled professional is sought to oversee the assessment of extractables and leachables (E&L) risks for materials based on supplier information. The ideal candidate will have a comprehensive understanding of E&L test data, analytical strategies, and design.
Key Responsibilities- Assess the risk level of E&L and update the risk assessment using supplier information.
- Develop a library of materials backed by corresponding E&L test data.
- Coordinate efforts for extractables studies or product-specific leachable studies.
- Prepare E&L risk assessments, testing protocols, and reports.
- Bachelor's degree in pharmacy, pharmaceutical technology, chemical engineering, biotechnology, chemistry, or equivalent science fields.
- Minimum 8 years of experience in MS&T or manufacturing of pharmaceutical drug substances and products for small and large molecules.
- Familiarity with regulatory guidelines on ICH Q3, validation, product filing, and post-approval changes.
