Provide support regarding equipment deviations and coordinate with the equipment management group for supplier contacts. * Drive and represent the QC in analytical lifecycle management initiatives for the legacy portfolio. * In-depth understanding of QbD, Quality Risk Management and lifecycle management principles, and relevant regulatory framework, such as ICH Q8, Q9, Q10, Q11, Q12. * 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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