Oversight of activities related to risk assessment of Dexcels products, root-cause investigations and management of CAPA activities associated with risks for Nitrosamine formation.
Responsibility for conducting and managing of risk assessments and investigations related to nitrosamines in a standardized way in accordance to plan, employ critical thinking, best compliance practices and apply chemical knowledge to identify root cause for Nitrosamine formation and specify CAPA related to active pharmaceutical ingredient formulation, and/or finished drug product manufacturing control strategy.
Routine interaction between different Dexcels units, manufacturing sites (Dexcel, Apis/Exipients, CMOs manufacturing sites etc.), and external experts to enable collection and assessment of relevant and up-to-date information.