北京招聘

Key Responsibilities:

1.Implements and executes global Merck group quality policies and strategy within Skywing to ensure conformity with legal and company requirements.

2.Be responsible for development and implementation of GMP, ISO and SOP standards

3.Leads the QA team and ensures that quality related tasks are performed in accordance with good manufacturing practices, company quality policies as well as national and international regulations

4.Leads the implementation of a system for quality process measurement and aiming at controlling quality and identifying areas for improvement.

5.Manages activities such as audits, regulatory agency inspections, or product recalls.

6.Processes ownership of complaint, deviation and change management, including the definition and follow up of corrective and preventive actions

7.Develops regulatory strategies and implementation plans for the preparation and submission of new products.

8.Be responsible for the product registration/ certification with the support of Regulatory Affairs.

9.Be responsible for the development of QA team, building capabilities and enhancing performance

10.Supervises a team of professionals (e.g. quality professionals and quality technicians)

11.Be part of the global QA management network



Personality Attributes :

1.Mature and self-motivated

2.Conscientious

3.Systematic and considerable

4.Ability to deal with conflict

5.Bachelor or Master Degree in Biology or pharmaceutics areas

6.Minimum 8 years solid experience in quality management/quality assurance/ quality control in biology or pharmaceutical manufacturing environment

7.Strong GMP and auditing background within the Pharmaceutical industry

8.Skilled in use of Word, Excel and PowerPoint software, experiences of SAP or other ERP system would be a plus

9.Good analytical skills, and ability to identify risks to quality and business and evaluate their magnitude and potential impact

10.Strong verbal and written communication skills

11.Good command of English

      北京清大天一科技有限公司是中国生物制药行业领先的细胞培养基、生物反应器和细胞大规模培养技术服务的供应商。公司坐落于北京市昌平区。2011年1月6日，德国达姆施塔特 – 德国默克集团宣布以100%股份全额收购北京清大天一科技有限公司。默克化工在中国拥有员工600余人，总部位于中国上海，其分支机构和销售团队覆盖中国市场18个主要城市。
    公司定位——生物制药支撑技术提供商
    公司发展战略——坚持技术创新
    吸收消化国际生物制药行业先进技术和理念，结合中国生物制药行业市场需求和发展趋势，不断创新技术和产品，为客户创造价值，促进中国生物制药技术发展。