北京招聘

Job Title: QA Manager

Reports To: General Manager – China

Dotted line to: Quality Director (in UK)

Group/Division: BSD/FCS China

Career Band: III

Job Track: Management

Position Location: Suzhou China

Number of Direct Reports: 3-4

Day/Shift (if applicable): N/A

FLSA Status (Exempt/Non-Exempt): Exempt

Position Summary: Responsible for managing all quality aspects in Suzhou facility from external supplier QA management and internal QA management and to ensure that the operational business is in compliance with cGMP and Fisher Clinical Services Global SOP.

Job Duties & Responsibilities

1. Manage all quality issues (complaints, recalls, change requests, counterfeits and product tampering, stability failures, annual self-inspection etc.)

2. Responsible for increased GMP overview (annual product review, major and critical deviations, assessment of quality trends and driving continuous improvement for processes and product quality performance

3. Responsible for quality process review including CAPA, Change Control, Batch review and validate the implementation.

4. Lead GXP audits, client auditing

5. Responsible for the training management of SOP and GXP.

6. Responsible for the validation of the equipment, facility and mapping.

7. Participate in the supplier qualification.

8. Involved in the supplier auditing program and responsible for the respective follow-up

9. Maintain and manage documents related to the audits, complaints and change requests in Trackwise

10. Responsible for lead and manage QA department to ensure all business process in compliance with cGMP and Fisher Clinical Services Global SOP

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

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。