MSAT Process Lead

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Our offer Role summary Provide technical leadership within Manufacturing Science and Technology by defining and maintaining the processes as part of Tech transfer / NPI activities such as, ICH-Q3 risk assessments and testing strategies Establishment of an end‑to‑end process for materials management (raw materials, process consumables, single‑use components). Translate GMP and regulatory expectations into robust risk management strategies, ensuring compliance and reliable manufacturing & supply. Your mission Key responsibilities Lead and author ICH Q3 risk assessments: Perform risk identification, quantification, and control strategy definition for process‑related impurities derived from materials of construction of product contact materials. Define and justify risk monitoring testing strat…

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