QC负责人

负责扬州工厂的QC实验室的管理，分析方法的转移、验证及稳定性考察等。

Key Responsibilities 主要职责

1. Responsible for the management of QC laboratory and strengthening the standardization and normalization of QC laboratory.

负责QC实验室管理工作，加强QC实验室的规范化与标准化。

2. Responsible for analytical methods transfer and validation/verification, establish relevant specifications and test methods.

负责检验方法的转移接收，验证或确认并形成相关的检验SOP。

3. Responsible for training internal personnel on quality system, GMP, and regulations; Ensure that QC person receives appropriate training and obtain relevant qualifications.

负责内部人员质量体系知识, 药品生产管理规范、法规的培训；确保检验人员均获得相应的培训，并取得相关资质。

4. Responsible for reviewing batch analytical records and reports, reviewing analytical method transfer reports, stability study data and reports. Ensure that intermediate products and finished products are inspected according to the predetermined inspection plan and quality standards.

负责审核批检验记录和报告，审核检验方法转移报告，稳定性研究数据及稳定性研究报告。确保中间产品和成品按预定的计划和质量标准进行检测。

5. Participate in the establishment, maintenance and review of QMS, collaboration with QA department for deviation/OOS/OOT investigation and handling, close CAPA, and conduct risk assessment reports.

参与GMP质量体系建立、维护和回顾，配合QA部门进行偏差/ OOS/OOT/调查和处理， CAPA关闭，风险评估报告等。

6. Review and approve the maintenance plan and annual calibration and verification plan for QC equipment and facilities, review and approve the annual review report of QC equipment and facilities.

QC设备设施维护计划和年度校验检定计划制定、变更、批准，对设施的年度运行报告进行审核、批准。

7. Drive continuous improvement of the company's quality system, provide suggestions and planning for the company's quality strategy.

促进公司质量体系持续改进，对公司质量策略提供建议和策划；

8. Participate in NDA activities; Support self-inspection and audit management.

参与新药注册申报；支持配合公司的自检和审计管理。

9. Participate in material and vender management.

参与物料和供应商管理。

10. Complete other tasks assigned by superiors.

完成上级领导交办的其它工作。

Qualification and Experience 能力与经验

Education/Qualifications 教育程度/所获资格证书

1. At least a bachelor's degree or above in analytical chemistry, microbiology, biotechnology/bioengineering, biopharmaceuticals, and other related fields.

分析化学、微生物学、生物技术/生物工程、生物制药及其它相关专业大学本科以上学历。

2. At least 10 years working experience at pharmaceutical QC management.

至少具有10年以上制药企业QC管理工作经验。

Job Required Competencies 岗位所需胜任力

1. Familiar with USP, EP, and Chinese Pharmacopoeia, with a deep understanding of pharmaceutical quality control strategies.

熟悉USP，EP和中国药典，对药品质量控制策略有较深的理解。

2. Familiar with FDA, EU GMP, and Chinese GMP, familiar with relevant regulations on biopharmaceuticals.

熟悉FDA，欧盟GMP和中国GMP，熟悉生物药相关法规。

3. Has strong communication, coordination, management, planning, and execution abilities.

具有较强的沟通、协调、管理、计划与执行能力。