南京招聘

？ Four Main Responsibilities:
Job Weighting% Main Responsibilities

40%
Documentation management, batch release and complaint handling

35%
Establish, maintain and continue improve quality system
20%
Regulatory Affairs

5%
Others

？ Major Responsibilities/Activities:
There are three major responsibilities about the position.
1. Coordinate activities of documentation management, batch release and complaint handling
2. Establish, maintain and continue improve quality system.
3. Coordinate / support Chinese regulatory activities.


? Documentation management, batch release and complaint handling

o Quality System and Document Control
a) Maintain and develop the quality and food safety management system documentation through well organizing the inputs from plant site team. Keep continuous improvement to the quality and food safety management system
b) Coordinate the documentation preparation, review and approval for quality system through plant site.
c) Ensure the documentation in compliance with Abbott and Abbott Nutrition polices/guidelines/procedures by review and internal audit on documentation.
d) Well inform the operation of QDMS to plant site and ensure the correct operation, and well maintain the QDMS.

o Batch Release
a) Review product batch records for product release to ensure all the released products are in compliance with the plant site specifications/ procedures.
b) Maintain the batch record retention in compliance with the related policies.
c) Coordinate the product traceability/mock recall.

o Complaint Handling
a) Optimize and execute site compliant handling procedures in compliance with Corporate/Divisional requirement.
b) Collect, summarize and report any feed back on product complaint from any resources.
c) Coordinate the compliant investigation with delivering prompt reply/report.
d) Deliver Complaint Handling report in timely manner to support AMR Metrics reporting and AMR meeting.
e) Forward any opportunities to reduce complaint and continuously improve product quality.

? Establish, maintain and continue improve quality system

o Self-assessment and internal audit
a) Promote self-assessment and compliance through the plant site regarding quality
b) Set up annual internal audit plan, and ensure the internal audit against agreed plan.
c) Be familiar with GMP requirement and lead / coordinate the GMP walk down inspection.
d) Improve GMP self-inspection practices & ways of working at site.
e) Coordinate to set up action plans to quality compliance observations.
f) Follow up the implementation of action plan, to ensure the action plans implemented effectively.

o Global internal audit
a) Organize the preparation for AQR/AN audit readiness, and coordinate the AQR/AN audit to ensure the successful audit.
b) Coordinate to set up action plans to quality compliance observations.
c) Follow up the implementation of action plan, to ensure the action plans implemented effectively.

o External inspection/audit
a) Organize the preparation for HACCP/GMP/ISO audit readiness, and coordinate the HACCP/GMP/ISO audit to ensure the successful audit.
b) Coordinate the authority inspection/audit, ensure to compliance with authority regulatory requirement.
c) Coordinate to set up action plans to quality compliance observations.
d) Follow up the implementation of action plan, to ensure the action plans implemented effectively.

? Regulatory Affairs

o Hygiene/manufacturing permit & label registration
a) Get related hygiene/manufacturing permit & registration in compliance with China regulatory/codes.
b) Organize artwork review within related departments in manufacturing site, and cooperate with Marketing and Regulatory for artwork approval.
c) Keep the related China regulatory/codes updated from Abbott Regulatory Team or authorities, and well inform Abbott related people for consistently compliance.
d) Keep authority test reports updated to support sales in product market entry.

o Lead, manage or support all regulatory inspection preparation activities.

? Others
a) Organize or coordinate GMP, GDP, compliance and audit skill training to plant site on demand.
b) Implement other assignments allocated by the Supervisor
c) Follow all EHS rules and procedures for QA department.
d) Attend all required EHS training and activities.


8． REQUIREMENTS:
？ Industry experiences:
Extensive experience in Food, Nutritional or Pharmaceutical manufacture, quality control is preferred.

？ Position experiences:

- Quality Control and coordinating Quality system documentation experience 3 years or above.
- Work knowledge and experience of quality system document preparation, implementation and maintenance, batch record review for product release.
- Familiar with ISO 9001, IS0 22000 and HACCP is preferred.

？ Language Skills：
Good command of spoken & written English

？ Computer Skills:
Good systems capabilities and experience with MS office tools
？ Mobility:
NA
？ Certificate Required:
NA
？ Other Special requirement:
NA

雅培始终致力于帮助人们生活得更加美好。我们带来改变生命的前沿科技和产品，缔造医疗健康的未来。我们的创新产品帮助人们改善健康、强健体魄、快速诊疗，助力人们回归到所热爱的生活中。
公司的全球总部位于芝加哥，领先的产品和服务遍及医疗器械、诊断、营养品、药品等领域。雅培全球109,000名员工，每天助力160多个国家和地区的千百万人获得健康，拥有更美好的生活。
我们植根中国超过30年，拥有4家工厂，3家研发中心，1家客户体验中心，1家培训中心。我们在中国拥有超过6,000多名员工,总部位于上海，连续10年荣膺"中国杰出雇主"，致力于帮助人们活得健康，活出精彩。
在雅培，我们致力于帮助人们在我们所做的每一件事上过上更充实的生活。我们正在通过改变生活的技术和产品创造医疗保健的未来，这些技术和产品使您更健康，更强壮，快速识别您何时有医疗需求，并治疗病情以帮助您重新做自己喜欢的事情。
我们的全球总部位于芝加哥，为 160 多个国家/地区的人们提供领先的医疗设备、诊断、营养产品和品牌仿制药。我们中的109，000人正在帮助世界各地数百万人过上更好，更健康的生活。
在中国，30多年来，我们一直在帮助人们过上充实的生活。我们有4个生产基地，3个研发中心，1个客户体验中心，1个培训中心。雅培在中国拥有6000多名员工，总部位于上海。雅培连续10年被认证为中国"杰出雇主"，帮助人们健康生活，生活充实。