职位描述
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职位职能:
??质量管理/测试工程师(QA/QC工程师)??体系工程师/审核员
职位描述:
岗位职责：
1. Quality Document System 质量保证体系文件：
Write position related SOPs by both English and Chinese when needed.
确保文件体系结构与文件格式符合GMP要求。编写个人岗位工作有关的SOP，必要时，英汉双语。
2. Batch Review物料和产品批审核
Collect batch records relevant departments and review batch records in time, ensure that batch material and the product to release in time.
负责接收来自生产部、物管部、质控部的批记录；整理、审核每批物料和产品的批记录，确保物料和产品及时放行。
Communicate with the manufacturing site about the quality defects of bulk product.
负责与生产厂联系待包装品供货缺陷。
3. Printed packaging materials artwork control标签类印刷包装材料的印前管理：
Ensure that the printing packaging material meet the requirements of SFDA regulation.
管理标签类印刷包装材料的制订和修订改版符合药监法规的要求。
4. Responsible to organize annual product quality review负责组织定期的年度质量回顾
Ensure annual product quality review accomplished in time. pre
确保质量回顾及时完成。
Write summary report of annual product quality review for management approval.
编写年度回顾的总结报告提交管理层批准.
5. Quality specification and stability studies质量标准和稳定性研究：
Review quality specification. Ensure the specification compliance with GMP and pharmacopeia requirements
审核质量标准，确保标准符合GMP和药典标准要求。
Be responsible for review analytical method validation.
负责审核分析方法学的验证文件。
Write stability study protocol. Check the implementation of the stability tests on-line.
制订稳定性研究方案。定期跟进稳定试验进度。
6. 验证支持support qualification and validation
Review IQ/OQ/PQ periodical report.
审核IQ/OQ/PQ阶段性验证/确认报告。
7. Deviation/OOS/Change control/CAPA 偏差、OOS、变更、CAPA
Review deviation, change control and OOS investigation document related with batch review and ensure there is no adverse impact on the batch quality before release batches.
审核与批产品和物料有关的偏差、变更和OOS调查文件，确保偏差、变更、OOS对批质量无负面影响。
Implement CAPA action related.
执行批放行职责范围内的CAPA行动。
8. Communicate with Zhuhai SFDA负责与珠海SFDA的联系
Keep communication with city SFDA to response SFDA requirement timely
与市药监部门保持联系，及时回复药监局的要求。
JOB PROFILE (Education & Experience)
岗位要求 (
学历及经验)
Education 学历
Bachelor or above degree of Pharmacy or relative profession.
药学/制药专业或相关专业，本科及本科以上学历。
Experience
经验
At least five years working experience for drug manufacturing or quality in pharmaceutical enterprises.
五年以上从事药品生产技术或质量管理工作经验。
