In-depth understanding of QbD, Quality Risk Management and lifecycle management principles, and relevant regulatory framework, such as ICH Q8, Q9, Q10, Q11, Q12. * Drive complex scientific / quality investigations in your field in a cross-functional team and facilitate related remediation plans (e.g., CAPA plan). * Promote quality awareness and proper adherence to GMP. * Provide support regarding equipment deviations and coordinate with the equipment management group for supplier contacts. * Explore, evaluate, and introduce new equipment and new analytical technologies in your field to ensure the laboratory evolves with increasing quality requirements and standards, while maintaining personal scientific expertise. * Drive and represent the QC in analytical lifecycle management initiatives for the legacy portfolio. * Understanding of the principles of risk-based small-molecule process control strategy ...
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