Responsible to ensure compliance to cGxP standards for products within area of responsibility (during development, transfer and commercialization) and product release.

Provide guidance, support and leadership to teams within area of responsibility. Functionally report to QA Operations Lead

Major accountabilities:

Operational

•Local SOP initiation

•Documentation Management and archiving

•Training management and compliance tracking

•Support validation activities

•CAPA management and follow up

•Support NDA dossier readiness

•Collaboration in GxP audits/inspections

•Oversight of Quality Operations

•Batch Record review

•QA Operational Excellence

•Complete other tasks be assigned by line manager

•Might run shifts to support product release according to business needs.

HSE

•Promote and improve the Safety and Quality cultures, by implementing the necessary systems and actions in line with the evolution of the project

•Ensure overall inspection readiness for area of responsibility.

•Guarantee the effectiveness of the Business Continuity Plan

•Being part of the project crisis management team and depending on skills, expertise and experience can be appointed to one of the NEM roles (Novartis Emergency Management). By delegation of the project Manager may be required to take decisions and take the necessary actions, in particular within the framework of the on-call management system.

•Responsible for participating in initial training and retraining

•HSE incidents reporting & action follow-up

Key Performance Indicators

•No project delay caused by the unit

•No critical observations during authority inspections

•No delay with new product introductions caused by the unit

•Timely closing of deviations/complaints

•Achieve project quality budget

•Timely closing of deviations/ complaints.

Ideal Background

Relevant Experience

•Minimum: 3-5 years’ experience in the field of Quality Assurance and

•Sterility Product Manufacturing in a pharmaceutical industry environment or equivalent

•Sufficient experience on audit and inspection preparation and management

•Deeply understanding on cGMP

Education & Qualification

•University degree in Pharmacy, Engineering, Chemistry, Biotechnology or equivalent

Languages

Fluent (oral and written) in English

local language desired

Competencies

•Collaboration

result-oriented

•Advanced communication skills

•Risk Management

•Audit Management

Health Authorities

Technical Launch and Transfer

•Knowledgeable on GMP Quality Assurance and Manufacturing Process/Product Expertise

•Expertise in GxP operations

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?

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up. You can follow us via Novartis Recruitment WeChat Official Account and Novartis Recruitment WeChat Video Account.

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

Quality Control (Qc) Testing

Continued Learning

Technological Intelligence

Dealing With Ambiguity

Quality Standards

Qa (Quality Assurance)

Gmp Procedures

Technological Expertise

Self-Awareness