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:

• Preparation of process and cleaning validation documentation (Protocols, reports) as well as change evaluations for new product launches and Life cycle management activities.
• Ensure project tracking documentation/tools are updated according to plan
• Collaborate closely with the development organization (or sending site) for technical transfers and new product launches to ensure knowledge transfer, appropriate control strategies, risk analysis and control, and readiness for commercial process validation
• Ensure that data integrity checks are conducted to verify that all the data is complete, consistent, and free from errors before proceeding with any further analysis or reporting
• Coordination of documentation review with the site MS&T, QA, and QC, also Reg CMC where applicable
• Preparation, approval and life cycle management of Gxp documents

Experience:

• Bachelors degree in pharmacy, Pharmaceutical Technology, Chemical Engineering, Biotechnology, Chemistry, or equivalent science streams. Desirable MSc/MS. or equivalent experience.
• Min 8 years of experience in MS&T or in the manufacturing of pharmaceutical Drug substance and Product for Small and Large molecules.
• Should be familiar with regulatory guidance on ICH Q3,Validation, Product filing and Post approval changes.
• Proven project management experience in a cross-functional environment (e.g. multi-site, technical development, other functions).
• Expertise in reviewing and writing technical reports
• Good communication, Presentation and Interpersonal skills.
• Proficiency in English (oral and written) is required.