Over 30 years outstanding operations in Novartis Changping site, Beijing. We are equipped with most state of the art technology across solid and liquid manufacturing and packaging process, including up to 500 million cartons per minute high speed packaging line. More than 3 billion units of medicines are packed by our team in one year. We deliver high quality, affordable medicines on time, every time, safely and efficiently to our patients.

Your key responsibilities:

Your responsibilities include, but are not limited to:

•Act as Subject Matter Expert (SME) for product and process, provide technical support to production front line for process-specific issues to ensure smooth production plan execution

•Ensure that all batch manufacturing documents and SOPs are up to date per version control or change execution in relevant DMS (Document Management System) and/or MES (Manufacturing Execution System), and are available for validation/revalidation of processes per required timelines

•Ensure timely handling of deviations, complaints and relevant non-conforming issues where applicable, in an effective and timely manner, by using proper investigation tools /methodology as well as proper CAPA defined and/or implemented

•Ensure proper management of various technical projects assigned: coordinate with relevant functions and teams throughout the project stages to ensure timely completion and handover to operation team, and in compliance with cGMPs and HSE

•Participate or take lead in OpEx continuous improvement projects, such as on OAE\Yield\ productivity or simplification of complexity etc.

•Prepare, support and follow-up of Health authority and internal inspections and collaborate with Regulatory Compliance for dossier submissions, revisions where necessary.

•Provide inputs and contribute to quality system implementation, quality and HSE relevant gap and risk assessment etc.

•Support shop-floor people’s technical development and by providing proper inputs or delivery of trainings or materials

What you’ll bring to the role:

•University degree or above in Pharma science or technology, Bio- or chemical engineering etc. with solid experience in pharma or biopharma industry

•Minimum 3 years experience in a GMP manufacturing environment, i.e. a production technical role or relevant roles for equipment qualification or process validation etc.

•Good technical learning, mastery and understanding about manufacturing process and equipment, preferably with experience in aseptic manufacturing and/or bio-pharma manufacturing or process validation etc.,

•Fluency and proficiency in both English and Chinese as working languages

•Good understanding of cGMP and regulatory requirements across multiple health authorities

•Hands on experience in a digitalized working environment, i.e. work with MES (Manufacturing Execution System) and relevant ERP (Enterprize Resource Management, e.g. SAP), eDMS (Document Management System) etc.

•Team player with strong sense of collaboration, effective communication and influencing skills

为什么选择诺华：帮助患者及家属不仅需要创新科学，还需要一支包括你我他在内的充满智慧与激情的团队，大家相互协作、支持与激励。共同实现突破，改变患者的生活。一起共创更好的未来，你准备好了吗？

加入我们的诺华网络：这不是您心仪的职位？欢迎加入诺华人才社区，与我们保持联系，及时了解合适的职业机会。您也可以关注诺华集团招聘微信公众号及诺华集团招聘微信视频号。

薪酬与福利：您可以前往诺华官网了解我们帮助您实现个人与职业发展的举措。

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?

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Benefits and Rewards: Go to Novartis career website to learn about all the ways we’ll help you thrive personally and professionally.

Manufacturing Process

Knowledge Of Capa

Scheduler

Risk Management

Employment Discrimination

Good Documentation Practice

Lean Manufacturing

Chemical Engineering

Technology Transfer

Process Control

Production Line

Manufacturing Production

Well-Being

Change Control

Physics

Flexibility

Continual Improvement Process

Root Cause Analysis (RCA)

Efficiency

Knowledge Of Gmp

Productivity

General Hse Knowledge