Drive complex scientific / quality investigations in your field in a cross-functional team and facilitate related remediation plans (e.g., CAPA plan). * In-depth understanding of cGMP principles and relevant regulatory guidelines in the analytical area, such as ICH Q1, Q2, Q3/A,C,D, Q7, Q14, M7 relevant USP and Ph. * Liaise with relevant organizations, such as QA, chemical production, R&D, CMC RA and build a network of contacts to support troubleshooting. * Develop fit-for-purpose standards and guidelines applicable to the QC analytical laboratory to achieve both scientific excellence and regulatory compliance in a commercial QC environment where New Product Introduction is in strategic focus. * Experience across different phases of pharmaceutical development is a plus * Ability to work independently in a dynamic environment, handle multiple tasks, and collaborate effectively.
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