QC Scientist ( Micro Testing)
上海勃林格殷格翰药业有限公司
- 公司规模:1000-5000人
- 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:2017-11-23
- 工作地点:上海-浦东新区
- 工作经验:无工作经验
- 学历要求:专业培训
- 职位月薪:20-30万/年
- 职位类别:药品生产/质量管理
职位描述
职位描述:
Description:
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
Duties & Responsibilities:
-Conduct routine and complex microbial testing for raw materials, packaging materials, intermediates, bulk products and finished products, sampling and testing for purified water ,water for injection and environment monitoring etc. 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.
-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 requirement.
-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.
Requirements:
-Finish all tests correctly according to agreed timeline.
-All documents are prepared timely and comply with GMP and BI requirement
-Complete timely.
-Efficiency of the method.
-Compliance.
-Activities are delivered according to approved schedule and without any impact to the routine testing.
-Efficiency .
-Regular SOP review completion timeliness.
-Investigation close on time.
-CAPA close on time CAPA.
-Standardize of Testing Method.
-Transparency of reagent management.
-Task Times and effect .
-Take mentor responsibility internally.
-Training efficiency.
-Provide positive idea numbers to support the improvement of organization performance.
Desired Skills, Experience and Abilities:
-At least 3 years in Quality Control and/or in a manufacturing environment within the Bio-pharmaceutical industry. Multinational pharmaceutical company experience is preferred.
-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 time management skill.
Eligibility Requirements:
-Bachelor or above. Majored in Microbiology, Biochemical, Pharmaceutical or related discipline.
Our Culture:
Innovative medicines for people and animals have for more than 130 years been what the research-driven pharmaceutical company Boehringer Ingelheim stands for. Boehringer Ingelheim is one of the pharmaceutical industry’s top 20 companies and to this day remains family-owned. Day by day, our employees create value through innovation for the three business areas human pharmaceuticals, animal health and biopharmaceutical contract manufacturing.
Boehringer Ingelheim operates globally with approximately 50,000 employees. Since we are privately held, we have the ability to take an innovative, long-term view. Our focus is on scientific discoveries and the introduction of truly novel medicines that improve lives and provide valuable services and support to patients and their families. Employees are challenged to take initiative and achieve outstanding results. Ultimately, our culture and drive allows us to maintain one of the highest levels of excellence in our industry.
Description:
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
Duties & Responsibilities:
-Conduct routine and complex microbial testing for raw materials, packaging materials, intermediates, bulk products and finished products, sampling and testing for purified water ,water for injection and environment monitoring etc. 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.
-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 requirement.
-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.
Requirements:
-Finish all tests correctly according to agreed timeline.
-All documents are prepared timely and comply with GMP and BI requirement
-Complete timely.
-Efficiency of the method.
-Compliance.
-Activities are delivered according to approved schedule and without any impact to the routine testing.
-Efficiency .
-Regular SOP review completion timeliness.
-Investigation close on time.
-CAPA close on time CAPA.
-Standardize of Testing Method.
-Transparency of reagent management.
-Task Times and effect .
-Take mentor responsibility internally.
-Training efficiency.
-Provide positive idea numbers to support the improvement of organization performance.
Desired Skills, Experience and Abilities:
-At least 3 years in Quality Control and/or in a manufacturing environment within the Bio-pharmaceutical industry. Multinational pharmaceutical company experience is preferred.
-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 time management skill.
Eligibility Requirements:
-Bachelor or above. Majored in Microbiology, Biochemical, Pharmaceutical or related discipline.
Our Culture:
Innovative medicines for people and animals have for more than 130 years been what the research-driven pharmaceutical company Boehringer Ingelheim stands for. Boehringer Ingelheim is one of the pharmaceutical industry’s top 20 companies and to this day remains family-owned. Day by day, our employees create value through innovation for the three business areas human pharmaceuticals, animal health and biopharmaceutical contract manufacturing.
Boehringer Ingelheim operates globally with approximately 50,000 employees. Since we are privately held, we have the ability to take an innovative, long-term view. Our focus is on scientific discoveries and the introduction of truly novel medicines that improve lives and provide valuable services and support to patients and their families. Employees are challenged to take initiative and achieve outstanding results. Ultimately, our culture and drive allows us to maintain one of the highest levels of excellence in our industry.
职能类别: 药品生产/质量管理
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。作为连续七年通过“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!
想获取更多信息,有以下方式:
1. 访问************************************/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!
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。作为连续七年通过“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!
想获取更多信息,有以下方式:
1. 访问************************************/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!
联系方式
- Email:HRTACampusWest.CN@boehringer-ingelheim.com
- 公司地址:地址:span张江李时珍路257号