项目生产工艺专家

3 months ago

Nantong, China Bayer Full time

At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

项目生产工艺专家 

YOUR TASKS AND RESPONSIBILITIES

Lead the technical transfers (TT) from existing site to new site according to Bayer QMS and international cGMP / drug regulation requirements as required, including (not limit to, NLT): • Complete TT feasibility study • Complete TT gap analysis • Complete TT plan & report • Complete process specification development • Complete relevant validations, including process validation, cleaning validation, etc. Support production procedure development as required, including (NLT): • Optimize process specification management procedure • Optimize process validation procedure • Optimize cleaning validation procedure • Support master batch record development • Support operation procedure / record development Support production equipment / system deployment as required, including (NLT): • Support user requirement specification, risk assessment development • Support design review / qualification • Support validation masterplan development • Support commissioning and qualification activities, including computerized system validation activities • Complete assigned performance qualification activities • Complete assigned validation activities, including process validation, cleaning validation, etc. Support cGMP certification & product license application, by timely complete assigned product process related activities. Be responsible for assigned continuously product process optimization, production work process improvement, technical transfer & new product launch support, after site transfer.

WHO YOU ARE

Familiar with product process, especially solid tablet and liquid drug. Familiar with international cGMP and certification e.g. EU, Russia, US FDA. Excellent leadership, organizational and coordination skills. Fluent English communication in both written and oral. Strategic agility: Learning agility to develop clear perspectives on process innovation opportunities and challenges for projects. Analytical skill: Excellent ability to review and use data (e.g. quality data, in process data) to develop insights and support decision. Dealing with ambiguity: Effectively cope with variation or changes, make decisions and act without complete information; comfortable with risk and uncertainty. Communication and impact: Excellent presentation and influencing skill and ability to interact with executives or authority internally and externally.

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