[苏州]阿斯利康投资（中国）有限公司

职位：Specialist, Quality System, QA
发布时间：2026-06-11
工作地点：其它
信息来源：前程无忧(51JOB)
职位类型：全职
职位描述
专业1:英语
专业2:通信类
职能类别:药品生产/质量管理
Major responsibilities
In addition to the general description of the parent profile role for this job function, the following summarize key result areas, specific accountabilities and/or tasks, etc. associated with this job title include:

● Change Management Governance: Serve as champaign of site change management process. Maintain the site change management process, ensure compliance with current GMP requirements. Participate in EQV integration and implement global change control system at site as stakeholder per project timeline. Support Global change control process within the site/ function.
● Change Control: Review site-initiated change controls to confirm risks are thoroughly and scientifically assessed, mitigation plans are properly defined. Ensure change controls are appropriately addressed, approved and closed in accordance with QCM.
● Change Review Board: Organize and chair site level change control review meeting with experts (if appropriated) and stakeholders at frequency to ensure comprehensive discussion and alignment on change impact assessment and implementation plan.
● Regional Process: Participate in regional process network, provide feedback improvements/ concerns into regional change process champion.
● Global Change control: Laise with regional process champaign to facilitate sited initiated global change and local change approval, go live and closure.
● Performance: Actively monitor and review Key Performance Indicators at site/ function and escalate trends and signals to line manager, take immediate actions if needed.
● Coach all users at site/ function as local change control process champaign.
● Implement the business continuity plan (BCP) at site/ function as directed by the IT system owner.
● Hands-on support for change related regulatory submission across China/US/EU and timeline planning with RA.
● Participate in Quality Management Review, product review and corresponding quality review as change control champaign.
● Leads and influences other quality professionals across the organization to ensure consistent application and execution of key quality systems
● Participate in project teams created towards problem solving or specific issues, to ensure GMP and regulatory compliance
● Participate in internal self-inspection or external audit activities.
● Address observations, issues, or potential risks related to change control process, define and implement corrective and preventive actions.
● Proactively participates in company initiatives toward continuous improvement (New Products Introduction, GMP Improvement Programs, etc.) while providing guidance in the area of knowledge and deliver timely results while contributing to quality system improvement.

Education, Qualifications, Skills and Experience

● Education: Bachelor’s degree in pharmacy, Life Sciences, Biotechnology or related field; Graduates from 985/211 universities or reputable overseas institutions are preferred.
● Technical Knowledge: Proficiency in quality risk management and linking risk outcomes to validation/qualification, data integrity, and regulatory impacts.
● Regulations & Standards: Deep knowledge for China GMP, US FDA 21 CFR, EU GMP, PIC/S, ICH Q9/Q10, ATMP and data integrity related guidance. Ability to translate requirements into practical SOPs, workflows and training.
● Skills: Excellent communication and presentation skills, strong cross-function coordination capabilities, rigorous logical thinking, strong documentation aligned with ALCOA+.
● Language: Excellent English (spoken and written), able to communicate with global and regional team, and author high quality English documentation.
● Behavioral Attributes: Demonstrates strong ownership, self-motivation and execution. Excels at cross-functional collaboration and prioritization, drives continuous improvement. 公司简要介绍：
公司名称:阿斯利康投资（中国）有限公司
公司类型:外资（欧美）
公司规模:10000人以上
公司介绍:阿斯利康是一家以创新为驱动的全球综合型生物制药企业，不但拥有一支业内领先的庞大研发团队，更注重合作，先后有数位诺贝尔奖获得者曾和阿斯利康一起为创新药物产品的研发贡献力量。阿斯利康致力于研制、开发、生产和营销卓有成效的处方药品，并提供专业的医疗服务，在消化、心血管、中枢神经、呼吸、肿瘤、麻醉和抗感染等领域处于领先地位，名列《财富》杂志全球500强。
阿斯利康总部位于英国伦敦，全球员工61,500名。业务范围覆盖全球100多个国家和地区。
阿斯利康1993年进入中国，总部位于上海，现有10000多名员工，分布在生产、销售、临床研究和新产品开发等领域。阿斯利康坚持“立足中国，长远发展”的理念，长远规划，长线投资，扎根中国。2001年4月，阿斯利康投资1.34亿美元在无锡成立生产基地，2016年5月，阿斯利康宣布投资1亿美元建立阿斯利康中国创新中心，2016年，阿斯利康进一步在无锡生产基地投资3,500万美元，2008年11月，在无锡生产基地追加5,000万美元投资，2010年12月，阿斯利康在上海设立亚洲及新兴市场医药研发部门，2011年2月，阿斯利康临床操作中心落成，2011年10月，阿斯利康宣布在江苏省泰州市打造全新生产基地，2012年2月，阿斯利康中国物流中心签约仪式在无锡新区进行，投资额为4,000万美元，2012年6月，阿斯利康中国区总部在上海张江高科技园区开业，2014年1月，阿斯利康泰州中国医药城生产基地正式开业，2014年8月，阿斯利康中国物流中心项目奠基仪式在无锡新区举行，2014年9月，泰州供应基地一期项目开始正式进入商业化生产，2015年，在中国设立英国和瑞典之外的全球第三个药物制剂研发中心，2015年，投资5,000万美元，在无锡生产基地旁新建小分子药物研发生产基地，2015年12月，与药明康德签署战略合作协议，共同在华生产创新生物药。阿斯利康还致力于履行企业的社会责任，并得到了各方面的高度评价。
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