Expert - Extractables & Leachables

Your responsibilities include, but not limited to :

• Understanding of Extractable and Leachable (E&L) risk assessment for materials based on supplier information and the ability to determine the risk level and update the Risk assessment.
• Building a comprehensive material library backed by corresponding E&L test data. Managing the coordination for Extractables studies or product-specific leachable studies.
• Preparation of E&L Risk assessment, E&L testing Protocol and Report. Compile E&L data and provide the information to Toxicologist for assessment. Proficient in risk evaluation, decision matrix, Gap Analysis, and outcome understanding manufacturing materials.
• Comprehensive knowledge of the chemical and physical properties (leaching tendency) of MOC materials. Skilled in defining the Original risk level, Mitigation factor, and Final risk level as part of the Risk Assessment process. Expertise in Extractable studies, their methodologies, analytical strategies, and design
• Expertise in setting the AET (Analytical Evaluation Threshold) and SCT (Safety concern threshold) for extractables and leachables detected during testing. Detailed understanding of E&L guidelines (SOPs, Pharmacopoeia and ICH standards, USP 665 & USP 1665 )
• Proficient in identifying and assessing the Worst-case material representative approach. Collect the material list and data information from development centres and manufacturing sites. Active participation in E&L taskforce and network meetings. Also responsible for coordinating with the development, Supply management, QC, and Production department.

What you ll bring to the role :

Essential Requirements :

Experience :

Skills Required

Interpersonal Skills, Communication, Gxp, lifecycle management , Project Management