Maintain daily contact with the supervisors of non-chromatographic release and IPC labs to ensure optimal support for testing laboratories. * Liaise with relevant partner organizations, such as QA, chemical production, R&D, CMC RA and build a network of contacts to support troubleshooting. * Provide support regarding equipment deviations and coordinate with the equipment management group for supplier contacts. * Participate in global compendial vigilance & compliance process by review compendial updates for “General Chapters” of EP, USP, JP, ChP, IP, and BP and by facilitating their fit-for-purpose local implementation. * Understanding of the principles of risk-based small-molecule process control strategy development, specification management (ICH Q6) and impurity management (ICH Q3 group of guidelines, ICH M7, latest regulatory standpoint on nitrosamines).
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