北京招聘

About Thermo Fisher Scientific

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of $17 billion and 50,000 employees in 50 countries. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Our four premier brands – Life Technologies, Thermo Scientific, Fisher Scientific and Unity Lab Services – offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support. For more information, please visit www.thermofisher.com.

The BioPharma Services Division (BSD) of Thermo Fisher Scientific is a cohesive group of businesses that play a critical/integral part in delivering life saving and life-enhancing therapies for tens of thousands of patients globally. BSD partners with pharmaceutical and biotech customers around the world to ensure the right patients get the right therapies in the right doses at the right time – a concept that we internally embrace as “There is a Patient Waiting.” Our unique blend of services include project management, packaging, distribution, transportation management and specialty logistics, ancillary supply management, clinical supply optimization, bio-repository storage, kitting and much more. Our nearly 3000 employees in over 16 countries work hard every day knowing that what they do matters. As a business we are committed to providing current and prospective employees with important factors that deliver compelling value: bright and interesting colleagues, challenging work, career development, and intrinsic rewards focused on serving patients.

All of our employees share a common set of values - Integrity, Intensity, Innovation and Involvement. Our ability to grow year after year is driven by our ability to attract, develop and retain world-class people who will thrive in our environment and share in our desire to improve mankind by enabling our customers to make the world healthier, cleaner and safer.

Position Summary:

To ensure that clinical supplies are handled and facility are maintained in accordance with established procedures and cGMP standards.

Maintain all necessary systems to ensure that quality assurance, and technicial activities, required to meet business needs are fully adequate, and that FCS Beijing fully complies with all legislation and industry recommended practice applicable to the distribution of clinical trial materials.

Key Responsibilities:

1. To ensure that all processes are performed in accordance with cGMP.

2. To conduct internal audits according to SOP requirement and regulatory consultation. Supplier and client audits.

3. Work closely with global QA in maintenance of QA procedures including the creation, approval, issue, distribution, and withdrawal of controlled documents.

4. Perform the leading role in the maintenance and administration of the Trackwise deviation and CAPA system in FCS Beijing.

5. Manage the change control system including approval.

6. Manage the validation and qualification programme for facilities, systems, shippers, and equipment.

7. Responsible for QA/GMP training of employees within the company.

8. To promote the business activities of Fisher Clinical Services ensuring global systems are implemented and maintained.

9. To support the business development of FCS by liaising with clients as necessary.

10. To maintain a professional standing as fully qualified pharmacist keeping fully up to date with regulatory issues as required.

11. Responsible for in-process inspection and carrying out checks before, during and after production.

12. Responsible for the release of incoming purchased or client materials and approves material specifications.

13. To perform QA Batch release.

14. To prepare new and updates existing SOPs.

15. Assist in the investigation of internal non-conformances through to resolution when required.

Minimum Requirements/Qualifications:

Education: Bachelor Degree, majoring in pharmaceutical or life science, pharmacy certificate will be plus

Years of Experience: > 7 yrs relevant working experience in pharmaceutical industry or life science industry, 3 yrs in manager level. Experience in QA management. Experience in primary packaging or clinical trials materials management will be preferable.

Knowledge: GXP regulations, clinical trial materials, QA management,

Competency: Detailed-oriented, Leadership, Problem Solving/Decision Making

Non-Negotiable Hiring Criteria:

1. Bachelor Degree, majoring in pharmaceutical or life science

2. 7 yrs relevant working experience in pharmaceutical industry or life science industry, 3 yrs in manager level.

3. GXP regulations, clinical trial materials knowledge

4. Good command in English

Fisher Clinical Services is a part of Thermo Fisher Scientific, the world leader in serving science, enabling our customers to make the world healthier, cleaner and safer. With annual revenues of $1 billion, we have more than 3500 employees and serve customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as environmental and industrial process control settings.
辉士尔临床服务是赛默飞世尔科学公司的一部分，该公司是服务科学领域的全球领导者，帮助我们的客户能够让世界更健康、更清洁、更安全。公司年收入为 10 亿美元，我们拥有 3500 多名全球员工，为制药和生物技术公司、医院和临床诊断实验室、大学、研究机构和政府机构等客户以及环境和工业过程控制设置提供服务。