职位描述
POSITION SUMMARY（职位概述）
Take the responsibility of QA engineer for ensuring product quality realized with applying QMS requirements, product specification, production process control plan, quality analysis tools.
确保产品质量控制活动遵循了质量管理体系、产品规范、生产工艺、控制计划的要求，并且应用恰当的质量分析工具。
KEY RESPONSIBILITIES（主要职责）
Production process management: check the quality control point for each key production steps, check the line clearance and cleaning results. Responsible for release of bulk product.
生产过程管理：对每批产品生产各环节的质量控制点进行检查， 对车间清场、清洁结果进行检查。负责车间半成品的放行。
Reviewing for incoming test of raw material. Reviewing for batch production record, batch analytical record.
审核到货检验结果。审核批生产记录和批检验记录。
Involve in root cause and action addressing to QN/deviation/CAPA. Involve in evaluation and action addressing to change control management.
参入质量事件/偏差/ CAPA的根本原因调查和措施跟踪，参入变更控制的评估流程和行动的跟踪。
Review validation protocol and validation report. And responsible of sampling for validation sample and monitoring for execution of validation activities.
审核验证方案和验证报告。在验证执行过程中负责取样并监督验证的执行。
Prepare relevant quality assurance procedure. Leading for preparing for control plan, p-FMEA, quality plan, etc
起草质量保证相关流程。领导建立控制计划、P-FMEA、质量计划等文件。
Responsible for sampling for product, retention sample and periodic inspection
负责车间取样、留样产品和周期检验。
Involve in supplier management, include supplier qualification evaluation, on-site audit, performance evaluation, compliant to supplier etc.
参入供应商管理，包括供应商初始确认评估、现场审计、供应商绩效评估、供应商投诉等。
Support operation engineer for investigation to customer complaint and review investigation report for the result corrective, and accurate addressing customer complaint.
支持生产部工程师对客户投诉进行调查，并审核调查报告及措施，精确解决客户投诉。
Aware to national standard/regulation requirements of products for driving product compliance.
了解国家标准和法规要求并推动产品符合相应的要求。
EHS compliance in the responsible area
负责区域的EHS合规。
Other superior assigned work
上级指派其它的工作。
SKILLS AND ABILITIES（技能）
Bachelor degree or above in the major of pharmaceutical technical relevant
本科或以上学历毕业，药学相关专业
At least 3 years relevant work experience of QA engineers or supervisors in pharmaceutical companies
至少3年以上医药企业QA工程师或主管的相关工作经验
Be familiar with relevant regulation requirements for drug, drug GMP requirements; medical device GMP/ISO 13485 requirements
熟悉国家有关的药品的法规、熟悉药品GMP要求、熟悉医疗器械GMP/ISO 13485要求。
team player with well communicative and cooperative,
具有良好沟通和协作能力的团队成员
Fluent in listening and speaking in English and Chinese
中英文听说读写流利；
企业简介
Founded in 1897, BD is a world-wide leader of medical technology which manufactures and sells a broad range of supplies, devices and systems for use by healthcare professionals, medical research institutions, industry and the general public. We focus strategically on achieving growth in three worldwide business segments-BD Medical System (Core Medical, Consumer Healthcare, Pharmaceutical Systems, Ophthalmic Systems), BD Biosciences and BD Preanalytical Solutions. Our products are marketed in the United States and around the world. The latest Fortune magazine has listed BD in the top four “America’s Most Admired Companies” in the medical products, equipment category.
We believed in “Do what is right, Always seek to improve, Accept personal responsibility, Act in harmony.” Now we invite qualified, talented and self-motivated individual to develop with BD’s businesses in China.
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