Liaise with relevant organizations, such as QA, chemical production, R&D, CMC RA and build a network of contacts to support troubleshooting. * Participate in global and local working groups to facilitate the implementation of state-of-art methodologies in your field (e.g., PAT, RTRT). * Provide support regarding equipment deviations and coordinate with the equipment management group for supplier contacts. * Understanding of the principles of risk-based small-molecule process control strategy development, specification management (ICH Q6) and impurity management (ICH Q3 group of guidelines, ICH M7, latest regulatory standpoint on nitrosamines).
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