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.

Quality Expert 

YOUR TASKS AND RESPONSIBILITIES

• Develop cGMP certification plan, and its tasks management and/or execution where appropriate per site product transfer strategy
• Finalize cGMP certification packages for submission to global stakeholders, track its process and/or DL address where if
• Individual cGMP certification on site inspection management under quality team support including (inspection confirmation, pre-requested documentation, receipt, inspection, post-inspection activities, grant certification, etc.)
• QMS analysis per marketing countries regulations and cGMP requirements
• QMS optimization tasks management to ensure system inspection readiness at the right time
• Individual optimization tasks E2E owner to ensure one streamline quality process fit for application health authority standard and operation needs
• Enabling cGMP practice maturity improvement
• Establish cGMP practice standards through templates, best practice
• Empower operation team and main stakeholders through GEMBA, training, shares, workshop, etc.
• Practice standards lifecycle management enhancing knowledge and capability continuously improvement

WHO YOU ARE

• Bachelor's degree or above in pharmaceutical or chemical related fields.
• At least 5 years` experience in pharmaceutical quality management.
• Having successfully experience in international cGMP certification and/or product registration e.g. EU, TGA, US FDA.
• International view and mindset for quality management and cGMP practice.
• Familiar with international cGMP and certification e.g. EU, TGA, US FDA. and/or registration regulations.
• Familiar with drug quality management, product process especially semi-solid drug and liquid drug.
• Excellent leadership, project management and communication skills.
• Fluent English communication in both written and oral. Special skills to be emphasized.
• Strategic agility – Learning agility to develop clear perspectives on quality 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 decision 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.

YOUR APPLICATION

If your background and personal experience fit this profile, please send us your complete application at www.career.bayer.cn If you have any recommendations, please kindly send mail to cnreferral@bayer.com
 

Location:                   

China : Yun Nan : KunMing 

Division:

Consumer Health 

Reference Code:

824586