Key Responsibilities As Analytical Subject Matter Expert (SME): Oversee day-to-day analytical activities at partner sites and external laboratories to ensure on-time delivery of analytical results and deliverables. Ensure compliance of release testing, data review, specification and monograph maintenance, PQR inputs, and analytical life-cycle management. Ensure compliance and timely follow-up of stability studies (protocols, reports, and results review). Support investigations (deviations, OOS/OOT) and change controls as needed. Manage activity-related administrative aspects such as purchase/work orders and invoices. Maintain clear communication with partners and stakeholders, fostering alignment and efficiency. Drive simplification, harmonization, and standardization of analytical processes where possible. In global project contexts: Lead validation,