北京招聘

职位描述：
Responsibilities:
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.
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. Responsible for Fisher Beijing’s quality system, cGMP & GDP system, safety management system, and ensures that the systems are managed and maintained effectively in accordance to the relevant standards.
9. To promote the business activities of Fisher Clinical Services ensuring global systems are implemented and maintained.
10. To support the business development of FCS by liaising with clients as necessary.
11. To maintain a professional standing as fully qualified pharmacist keeping fully up to date with regulatory issues as required.
12. Responsible for in-process inspection and carrying out checks before, during and after production.
13. Responsible for the release of incoming purchased or client materials and approves material specifications.
14. To perform QA Batch release.
15. To prepare new and updates existing SOPs.
16. Assist in the investigation of internal non-conformances through to resolution when required.

Minimum 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

Work Schedule: 08:30 AM TO 05:30 PM core hours, additional hours as required.

Preferred Qualifications:
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 举报 分享

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。