上海招聘Sr. QA Scientist

Sr. QA Scientist - BIO Pharma

勃林格殷格翰（中国）投资有限公司

公司规模：10000人以上
公司性质：外资（欧美）
公司行业：制药/生物工程

职位信息

发布日期：2019-06-24
工作地点：上海-浦东新区
招聘人数：3人
工作经验：5-7年经验
学历要求：本科
职位类别：质量管理/测试主管(QA/QC主管)

职位描述

Talent@Boehringer Ingelheim

About Boehringer Ingelheim

Join Boehringer Ingelheim and be part of a legacy where your growth is just as important as ours. A global, research-driven pharmaceutical company, we are one of the world’s top 20 leading pharmaceutical companies and have collaborated and innovated medicines in Human Pharma, Animal Health and Biopharmaceutical everywhere in the world for over 130 years. This is your chance to create ‘Value through Innovation’ with our internal and external partners to improve lives around the world, explore new scientific breakthroughs to stay at the forefront of our industry, and become a leader for future generations.

We continue to grow fast and are one of the top growing companies in the industry in China. Join us and be part of our continued journey to grow and achieve BI global Ambition 2025:

No. 1 in Animal Health
No. 1 in Biopharmaceutical Contract Manufacturing
No. 1 in value share for our brands in One Human Pharma

As a leading company, Boehringer Ingelheim thrives on passion, innovation and independence, and offers fulfilling work and growing opportunities to highly dedicated people. Certified as Top Employer in China in the past 6 continuous years, we help our people grow towards their success through high quality career development programmes and opportunities to lead international projects to develop into a leader of tomorrow. At the end of the day, your growth is our growth and vice versa.

For more information, please

visit https://www.boehringer-ingelheim.com/ or
follow us on LinkedIn, or
follow us on WeChat – JoinBI

About Biopharmaceutical Contract Manufacturing

As one of the world’s largest biopharmaceutical producers, Boehringer Ingelheim aims to become China’s first international provider of biopharmaceutical contract manufacturing solutions with all-round services to its clients in China and all over the world. The Company launched its world-class Biopharmaceuticals Manufacturing Site in China in 2017 with first-phase investment of more than EUR 70 million. This site is the first and only biopharma site in line with global standards set by a multinational pharma company in China, and has become a major milestone in Boehringer Ingelheim’s strategic blueprint for its biopharma business globally.

As the leader in biopharma CMO manufacturing, Boehringer Ingelheim introduces innovative business models into China to further promote development of China’s biopharma industry, boosting global competitiveness of Chinese biopharma companies, and facilitating clinical research and market launch of China’s innovative medicines in a bid to accelerate growth of China’s bio-technology industry. The Company’s state-of-the-art production platform, management system and global biopharma network will help bio-medicines made by Chinese companies to enter the global markets.

Job Responsibilities

To ensure continual improvement of processes and work sequences within processes and for the interfaces
Continuous critical review of the respective Status Quo in regard to the diverse KPIs and also the process parameters, to improve our daily work sequences
Participation as project leader, core team member or expert in the various Streams/Initiatives
Implementation of GMP assessment & oversight manufacturing areas release of plants or equipment for GMP work
Participation for audits as well as support of the experts in answering audit findings
Review of workflows for SOP and other GMP documents
Retrieve KPIs for QMR
Take the role of assigned local MSO to continuously improve the local QMS and support creations and revision of Biopharma Divisional Procedure
Ensure that the quality aspects of the deviation/CAPA/ OOS comply (contents, clarity, completeness)
Support of the lead investigators-carry out assigned deviations as Lead Investigator
Customer contact: information, coordination of commentary, requests for approval for deviations etc
Participation in the deviation & CAPA board
Prepare and distribute status reviews on deviations and CAPAs
For systematic deviations, create a further CAPA with the experts
Plan and carry out effectiveness check of CAPAs
Monitoring/ trending of deviations
Ensure that the quality aspects of the change requests comply (content, clarity, completeness)
Support for submitting the change request
Customer contact: information, coordination of comments, request for approval of CRs
Release of the change request for implementation
Definition and implementation of reflectivity checks
Monitoring/trending of changes
New client project QA support, like QAA build up, materials qualification, quality problem solving

Qualifications

Education/Degree Requirements: Bachelor Degree or above
Major: Pharmaceutical, Biopharmaceutical, Chemistry, Analytical
Language skills & proficiency: English fluent in read, speak, and write
Biopharma manufacturing knowledge include cell line technology, USP and DSP, mAb manufacturing, aseptic product manufacturing knowledge; GMP regulation expertise include FDA, EMA and CFDA
At least 5 years working experience in Aseptic Manufacturing Sites
At least 5 years QA working experience in GxP system as well as experience in working on an international level
Experience in authority inspections and company audits

Behaviours

Accountabilities – Even in ambiguous circumstances, always demonstrate ownership for decisions and actions
Agility – Quickly act with an open mind to face internal and external transformation
Intrapreneurship – Together with customers, come up with innovative ideas to respond to changing markets

Contact Us

If you think you can convince us that you are the right candidate we are looking for, apply now!

职能类别：质量管理/测试主管(QA/QC主管)

公司介绍

关于勃林格殷格翰
加入勃林格殷格翰，与我们一起携手并肩，共创未来。我们深信每一位员工的成长都将铸就公司的发展，每一位员工的努力也都将成就公司的美好明天。130余年来，研发驱动型制药公司勃林格殷格翰作为全球前20大制药企业之一，持续致力于人用药品、动物保健和生物制药合同生产三大业务领域，力争为人类和动物带来更多健康。加入勃林格殷格翰，将是您实现“创新展现价值”的绝佳机会！在工作中，您将通过与内外部伙伴的通力合作，站在知识迭代的最前沿；科研过程中，您将不断探索新型科学发现，切实提高全人类的生活质量；与此同时，您也将助力公司成为未来行业当之无愧的领导者。

我们的业务正处在持续高速发展之中，是中国业内发展最快的公司之一。我们诚邀您加入勃林格殷格翰，共同携手向前，成为实现2025愿景的一份子。

作为业内的领导企业，热情、创新和独立是驱动我们不懈前行的动力，我们为每一位努力热忱、恪尽职守的员工提供成长机会，实现其个人价值。作为连续八年通过“中国杰出雇主”认证的企业，我们通过提供高质量的职业发展规划、参与或领导国际项目的机会，为每一位员工的成功之路夯实基础。
让我们彼此成就，引领未来！

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1.    访问我们的官网,或
2.    关注我们领英账号, 或
3.    关注我们的微信公众号：BI招聘

行为准则
-责任心：即使情况不明朗，我们总是在自己的决策和行为中展现主人翁精神
-敏锐度：面对内外部变化时，我们以开放的心态快速应对
-内部企业家精神：我们与客户携手构筑创新理念，以应对瞬息万变的市场

联系我们
如果你坚信自己就是我们要找的人，不要犹豫，马上申请吧!

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