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質(zhì)量控制員-內(nèi)毒素
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職位描述
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 5 continuous years, we help our people grow towards their success through high quality career development programs 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
1. visit https://www.boehringer-ingelheim.com/ or
2. follow us on LinkedIn, or
3. 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
- Conduct routine and complex Endotoxin testing for raw materials, packaging materials, intermediates, bulk products and finished products, ensure to complete incoming analytical requests timely
- Conduct routine DNA residual testing for drug substance and drug product. ensure to complete incoming analytical requests timely
- Conduct routine virus testing of biological products. ensure to complete incoming analytical requests timely
- Establish Testing Specifications for Raw Materials, Packaging Materials and finished product, and relevant SOPs/Forms according to given instructions, ensure to comply with GMP, regulatory and BI requirements
- Participate in new analytical method establishment, validation and transfer to ensure efficiency and compliance of analytical method
- Execute lab equipment qualification and maintenance, ensure to perform all tests smoothly
- Assist supervisor to finish quality evaluation of abnormal sample and problem solving with professional knowledge and experience.
- Update SOP related to Product quality function according to business needs and regular review to ensure comply with GMP and BI global requirement.
- Perform tests and evaluation for supplier qualification, tests and investigation for compliant samples and defected materials in production, handle deviation and OOS investigation
- Maintain and optimize the testing procedure including management of equipment, glassware, reagent etc to continues improve the productivity and cost saving with comply with requirement from SFDA and company.
- Fulfill the other temporary task assigned by QC Supervisor
- Plan and conduct professional training programs for new staff in order to ensure skill of new staff can meet requirements.
- To participate organization activities.
Qualifications
- Education/Degree Requirements: Bachelor or above
- Major: Microbiology, Biochemical, Pharmaceutical or related discipline
- Language skills & proficiency: Good English writing, reading, listening and speaking
- Required capabilities (skills, experience, competencies):
- Good knowledge of GMP;
- Familiar with Ch.P, Ph. Eur and USP; Good team player;
- Good organizing and communication ability;
- Sense of urgency, precision and reliability;
- Willing to learn and open to new ideas, constructive thinking, initiative and proactive;
- Be able to work under pressure;
- Can create new idea or innovative method to multiple functions;
- Good coaching ability;
- Good time management skill
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 innovativeideas 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!
企業(yè)簡(jiǎn)介
世界知名的勃林格殷格翰集團(tuán)已有120年的歷史,業(yè)績(jī)出色。集團(tuán)總部設(shè)在德國(guó)殷格翰,全球范圍內(nèi),公司在100多個(gè)國(guó)家和地區(qū)擁有進(jìn)行研究開(kāi)發(fā)、生產(chǎn)和銷(xiāo)售的機(jī)構(gòu)。 1994年勃林格殷格翰集團(tuán)進(jìn)入中國(guó), 上海勃林格殷格翰藥業(yè)有限公司是其在華投資的高新技術(shù)企業(yè)之一, 業(yè)務(wù)集中于人體處方藥,一直以來(lái)公司各系統(tǒng)方面的研究功譽(yù)卓著。公司各種產(chǎn)品在全世界范圍內(nèi)得到一致好評(píng),近些年來(lái)產(chǎn)品銷(xiāo)量一直穩(wěn)居世界前列。
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上海勃林格殷格翰藥業(yè)有限公司
企業(yè)性質(zhì):外資企業(yè)
企業(yè)規(guī)模:100-499人
成立年份:1995
企業(yè)網(wǎng)址:http://www.boehringer-ingelheim.com.cn
企業(yè)地址:浦東大道138永華大廈22層
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職位發(fā)布日期: 2019-04-04