Specialist–MS&T

**Band** Level 3 **Job Description Summary** The purpose of the Specialist role is to work collaboratively with Biologics Site MS&T team and multifunctional technical operations teams in Large molecules platform. The individual plays a key role in facilitating effective communication between teams and supporting problem-solving activities. Maintain the oversight on Process, Transport validations, Extractable and Leachables activities, preparation and up dation of Risk assessments for Validation activities. **Job Description** **Key Responsibilities:** * Good understanding of Physico chemical buffer stability risk assessment, evaluation of corrosive agents as part of facility comparability assessment. * Monitoring compliance alerts related to raw materials, (e.g. check ß-Lactam structure, EG/DEG) * Experiences in preparation of Nitrosamine, Raw material risk assessments and declarations for residual solvents and Elemental Impurities. * Experienced in performing Extractable and Leachable (E&L) risk assessments, Gathering E&L data from suppliers, coordinating E&L studies, and maintaining accountability for the site during audits. * Preparation of Extractables and Leachables data for toxicological assessment * Create validation documentation including process validation protocol/reports, risk assessment, ongoing process verification (OPV) plans/ reports, cleaning validation protocol/reports based on alignment with Site Validation Lead. * Preparation of Transport Validation/Verification Protocols and conduct the necessary studies in coordination with cross functional teams. Collect the results and create the reports. Ensure all collected data is accurate and comprehensive and that protocols comply with regulatory requirements and organizational standards. * Support in preparation and up dation of Hazard Analysis Critical Control Point (HACCP), Control strategies. * Ensure the timely availability of technical documentation as per Novartis guidelines. Write Manufacturing P