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Sr. Project GMP Compliance Expert 

YOUR TASKS AND RESPONSIBILITIES

• Lead to develop lean, risk-based GMP systems for new site, to fully comply with latest China / Russia / EU regulation requirements and Bayer internal policies / procedures, while leverage existing site GMP systems andachieve cost competitive.
• Facilitate GMP execution at new site to effectively support new site construction, C&Q, validation, license application and site transfer.
• Work with QMS leader to develop / implement risk-based QMS systems at new site to effectively support new site C&Q, validation and technical transfer.
• Lead to review & confirm new site GMP related design, execution plan & result, to ensure all design & execution results fully comply with site GMP systems.
• Work with project C&Q leader to complete new site C&Q and B4 review as planned.
• Work with new lab leader to complete new lab design, C&Q, certification and transfer.
• Effectively facilitate GMP setup at new site to ensure its readiness before validation.
• Lead new site manufacturing license and product license application, including application strategy development, readiness preparation, readiness check and inspection coordination, etc.
• Effectively facilitate GMP culture buildup to fulfill new site launch plan.
• Complete other assigned activities as required

WHO YOU ARE

• Bachelor's degree or above, majored in pharmaceutical or chemical related fields.
• More than 10 years` experiencein pharmaceutical quality management; Having successfully experienced in international cGMP certification and/or product registration e.g. EU, TGA, US FDA is preferred.
• Familiar with China & international cGMP and certification, e.g. EU, TGA, US FDA. and/or registration regulations.
• Familiar with drug quality management, product process especially oral solid drug and liquid drug.
• Familiar with lean manufacturing system and risk-based quality management system.
• Excellent leadership and communication skills, result-driven mindset.
• Fluent English communication in both written and oral.