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. * Experience in late-stage development and API industrialization * In-depth understanding of QbD, Quality Risk Management and lifecycle management principles, and relevant regulatory framework, such as ICH Q8, Q9, Q10, Q11, Q12. * In-depth scientific familiarity with the typical non-chromatographic analytical technologies occurring in small-molecule API synthesis, such as solid-state techniques (e.g., particle size distribution by laser diffraction, XRPD), titrations (water determination by KF, potentiometric titrations), IR spectroscopy, UV spectroscopy, Raman, AAS, ICP-OES/MS. * Understanding of the principles of risk-based small-molecule process control strategy development, ...
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