344013BR
Apr 19, 2022
China

Job Description

18 million Chinese patients benefit from Novartis products! ~25,000 associates of more than 100 nationalities; 50+ manufacturing sites network located in 25 countries; ~70 billion units supplied to more than 150 countries in 2019 covering 5 therapeutic areas. Over 30 years outstanding operations in Changping, Beijing. We deliver high quality, affordable medicines on time, every time, safely and efficiently. We strive to become the top manufacturer of innovative and generic medicines in the industry - while keeping our patients at the heart of everything we do.

Your key responsibilities:
Your responsibilities include, but are not limited to:
• Personal skill: Act as Subject Matter Expert (SME) for the product and process, provide front line expert support for all process-specific issues to production by self-strong knowledge or new technology introduced.
• Project management: Participate or take leader in continuous improvement on OAE\\Yield\\ productivity and related projects; Drive the site collection, monitoring, evaluation and reporting of the site Quality KPIs
• Documentation: Ensure that all production documents are systematically up to date and that the production documents necessary for the validation / revalidation of processes are available
• Ensure the management of the various projects entrusted to him: coordinate the stages defined in the projects and ensuring timely completion and compliance with cGMPs and HSE
• Lead thorough Root Cause Investigation process using investigation tools and methodology Ensure timely treatment of deviations, complaints, OOE, OOS, and the implementation of effective CAPAs within agreed timelines
• Prepare, support and follow-up of Health authority and internal inspections and Collaborate with Regulatory Compliance QA for dossier submissions, revisions..

Diversity & Inclusion / EEO

诺华致力于打造一个卓越、包容的工作环境和多元化团队,代表我们服务的患者和社区。

Minimum Requirements

What you’ll bring to the role:
• University degree in Science is required, Pharmacy or Chemical Engineering, Pharmaceutical Technology or equivalent job experience
• Excellent written and spoken Mandarin and English
• Good scientific and technical (automation) understanding
• Team player with strong team spirit
• Good negotiator, Influencing and persuading as well as Change management, adaptability, ability to work under pressure
• Good understanding of regulatory requirements across multiple health authorities and Quality and compliance skills
• Good working knowledge/understanding of manufacturing execution systems (MES, SAP, or relevant...)

Desirable requirements:
• Minimum 2 year experience in GMP manufacturing process support role or Min. 2 year experience in the field of expertise for lower Education levels
• Preferably international company working experience
Why Novartis?
769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Novartis!

Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

Join our Novartis network: If this role is not suitable to your experience or career goals but
you wish to stay connected to hear more about Novartis and our career opportunities, follow us via Novartis Group WeChat Recruitment Account.
Novartis Technical Operations
NTO OPHTHALMOLOGY LOCAL MARKET
China
北京
全职
正式员工
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344013BR

Process Expert

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