公司簡介
諾華中國
所屬團隊
職位屬性
- 招聘類型：社招
- 工作性質(zhì)：全職
職位描述
To provide Quality Control and management expertise for the China RLT project in all quality related matters and to ensure that key aspects of the operational business comply with cGMP and regulatory requirements as well as the key Novartis corporate quality policies.
Role model with the Novartis technical expert framework and cultural aspirations. Functionally report to QC & AS&T lead.
About the role:
?As per the local project schedule to strictly complete and follow up QC actions/tasks timely. Escalate issue and work with internal and external stakeholders to resolve issue.
?Lead and complete equipment PQ in micro lab, analytical method transfers and method validation. Manage QC utility, standards, solvent, reagents, etc. to keep safety stock in lab and no impact will be caused by lacking or nonconformance. On time complete environmental monitoring test, water and gas test. Complete method validation protocol and report timely.
?Good communication and collaboration with global QC and AS&T experts to guarantee local quality milestones can be achieved.
?Initiate local QC procedures (e.g., SOPs, WI, Form, analytical method, etc.). On time complete testing for validation samples. Complete lab investigation if any OOX and/or deviation is occurred.
?Support audit and inspection
As the function SME to answer question from auditor and/or inspector without critical findings. Function representative to be involved in global and/or local project if any
?Introduction of new technologies
drives implementation of new requirements. Ensure QC activities executed according to cGxP standards
?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.
?Might run shifts to support product release according to business needs. Responsible for participating in initial training and retraining. HSE incidents reporting & action follow-up
Key Responsibilities：
?Minimum : 5-8 years’ experience in the field of Quality Control micro aspect in a pharmaceutical industry environment or equivalent
?University degree in Pharmacy, Engineering, Chemistry, Biotechnology or equivalent
?Fluent (oral and written) in English
local language desired
?Advanced communication skills
motivates colleagues and co-workers
?Being Resilient
Stakeholder Engagement
Operational Excellence
Applied Business Insights
?Risk Management. Audit Management
Health Authorities
Technical Launch and Transfer. Collaboration
result-oriented
?Expertise in GxP operations
Strong analytical background.
?MS Office applications and other standard IT applications supporting Quality activities
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? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf
Accessibility and Accommodation:
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
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: https://talentnetwork.novartis.com/network. You can follow us via Novartis Recruitment WeChat Official Account and Novartis Recruitment WeChat Video Account.
為什么選擇諾華：幫助患者及家屬不僅需要創(chuàng)新科學(xué),，還需要一支包括你我他在內(nèi)的充滿智慧與激情的團隊，大家相互協(xié)作,、支持與激勵,。共同實現(xiàn)突破，改變患者的生活,。一起共創(chuàng)更好的未來,，你準(zhǔn)備好了嗎？
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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? https://www.novartis.com/about/strategy/people-and-culture
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: https://talentnetwork.novartis.com/network. 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: https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf
任職條件
Continued Learning
Laboratory Excellence
Gxp
Total Quality Management
Decision Making Skills
Laboratory Equipment
Technological Expertise
Quality Control (Qc) Testing
Industry Standards
Dealing With Ambiguity
Quality Control Sampling
Self-Awareness
職位要求
- 學(xué)歷要求：無
- 工作經(jīng)驗：經(jīng)驗不限
- 外語要求：不需要