In-depth understanding of QbD, Quality Risk Management and lifecycle management principles, and relevant regulatory framework, such as ICH Q8, Q9, Q10, Q11, Q12. * Maintain daily contact with the supervisors of non-chromatographic release and IPC labs to ensure optimal support for testing laboratories. * Drive complex scientific / quality investigations in your field in a cross-functional team and facilitate related remediation plans (e.g., CAPA plan). * Liaise with relevant partner organizations, such as QA, chemical production, R&D, CMC RA and build a network of contacts to support troubleshooting. * Independently prepare, finalize, and/or review GMP procedures applicable to non-chromatographic laboratories of the QC. * Drive the local implementation of best practices in the non-chromatographic area by having fit-for-purpose guidelines in place and by creating classroom / hands-on training opportunities.
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