Analytical QC & AS&T Expert

Job description

Band Level 3 Job Description Summary: -Highly skilled and experienced laboratory professional who contributes by performing analytical release testing, investigational support, research support, and stability testing Job Description: Major Accountabilities: Lead and ensure execution of AS&T laboratory activities, aligning with plans, priorities, and production needs. Develop, validate, transfer, maintain, and monitor analytical methods throughout their lifecycle, in collaboration with TRD and external partners. Oversee analytical method transfers (TRD, sites, third parties) and support troubleshooting, investigations (OOS, deviations), and CAPA implementation. Ensure compliance with GMP, GLP, QMS, pharmacopoeia standards, and regulatory dossier requirements. Plan and coordinate QC & AS&T analytical activities, including stability studies, method performance monitoring, and risk management initiatives. Evaluate, implement, and qualify new technologies and laboratory equipment according to regulatory and company standards. Provide technical and analytical support to QC, including investigations and continuous improvement projects for quality, safety, and efficiency. Ensure proper doc...