北京招聘

Job Description

Job Title: QA Manager

Department: QA Department

Location: Beijing, China

Reports to: GM China

1. Job Summary

To ensure that clinical supplies are handled and facility are maintained in accordance to established procedures and cGMP standards. Maintain all necessary systems to ensure that quality assurance, and technical activities, required to meet business needs are fully adequate, and that FCS China fully complies with all legislation and industry recommended practice applicable to the distribution of clinical trial materials.

2. Job Duties and 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 China.

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 Fisher Clinical Services 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 prepares new and updates existing Standard Operating Procedures (SOP's).

15)Assists in the investigation of internal non-conformances through to resolution where required.

3. Requirement

1)Bachelor degree, preferably majored in Pharmacy or related. Registered pharmacist.

2)At least 5 yrs QA working experience in pharmaceutical or relevant industry.

3)At least 2 yrs experience in QA managerial roles.

4)Experience in internal auditing and host outside auditors.

5)Knowledge of cGMP, GDP, GSP

6)Previous knowledge of regulatory issues and drug dispensing.

7)Computer literate, good written and verbal English skills

8)Good working knowledge of Windows; numerate and literate.

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。