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
Being late phase center of excellence, Novartis Technical & Research Development (TRD) Changshu (Jiangsu province, China) site is responsible for around 70% of global Novartis New Chemical Entity (NCE) project portfolio. This role is critical for drug substance synthesis and process R&D analytical quality control strategy defining and execution by applying state of the art analytical technology, pharmaceutical industry regulations, as well as Novartis group systematic quality and compliance policies.
Major accountabilities:
?Defining the analytical strategy for development projects, including analytical method development and specification setting according to ICH or Novartis guidelines
contributing to regulatory Chemistry, Manufacturing & Controls relevant dossiers
effectively communicating and aligning the strategy with local and global project team stakeholders.
?Writing, checking, and/or approving analytical-related documentation, including testing monographs, method validation reports, transfer reports, instrument qualification reports, and SOPs.
?Leading investigations of Out of Specification/Out of Expectation results and Deviations, writing investigation reports, and defining corrective actions and preventive actions.
?Following cGMP regulations and Health Safety & Environment standards, and supporting Novartis internal and/or Health Authority inspections.
?Bringing Data & Digital ideas and solutions to the team and contributing to innovations.
?Enriching the organization culture by providing and implementing ideas and suggestions and coaching/mentoring junior colleagues.
Minimum Requirements:
Work Experience:
?Education background of analytical chemistry, pharmaceutical chemistry, medical chemistry
?Masters with minimal 8 years or PhD with minimal 3 years related working experience.
?Fluent & effective spoken, and written communication in English.
?Strong inter-personal stakeholder management skills.
?Good understanding of small molecular analytical technologies, e.g. HPLC, GC, titration, IR, NMR, LC-MS
?Pharmaceutical, nutrition, or food industry working experience, familiar with FAD, EMA etc. guidelines.
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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任職條件
the same as above