Senior Executive / Assistant Manager, Research & Development (Analytical).

* Drive the development and review of critical documents, including source approval records, AMV protocols, and standard operating procedures, to ensure compliance with US-FDA, TGA, UK-MHRA, and EU market requirements. * Lead the execution of analytical method validations, verifications, and transfers, adhering to ICH Q2(R2) guidelines for regulated markets. * Architect innovative analytical approaches, utilizing advanced techniques to reverse-engineer product formulations and optimize testing protocols. * Conduct comprehensive analysis of ophthalmic products, focusing on dissolution and particle size determination of ophthalmic suspensions, to ensure product quality and efficacy. * Manage and maintain a robust quality system, overseeing change control, incident management, deviations, CAPA, and QMS to ensure strict compliance with regulatory requirements. * Apply current EP, BP, USP, cGMP, GLP, and ICH guidelines to all analytical activities, ensuring adherence to industry standards and best practices. * Operate, maintain, and troubleshoot advanced analytical instruments, including ICP, GC, HPLC, and UV, performing IQ, OQ, PQ, and calibration procedures to ensure optimal performance and accuracy.