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供应商管理QA(J25243)

药明康德 · · 社招

信息来源:药明康德官方招聘查看原始链接 ↗薪资面议
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负责供应商资质符合性的监督与检查,确保产品质量与符合性,主要职责包括

职位描述

负责供应商资质符合性的监督与检查,确保产品质量与符合性,主要职责包括: Be responsible for the supervision and inspection on supplier qualification and ensure the product quality and compliance. The major responsibility includes the following:  负责供应商质量管理QA质量保证工作的执行。 Be responsible for Supplier Quality Management QA quality assurance work execution.  审核供应商相关文件,包括但不限于:调查问卷、资格证书、安全性声明和质量协议等,确保相关活动符合合全/客户和法规的要求。 Review supplier related documents, including but not limited to: questionnaire, certification, safety statement and quality agreement, etc., ensure related activities meet the requirements of STA/customer and regulations.  按既定程序批准供应商,并维护供应商档案。 Approve supplier according to approved procedures, and maintain supplier archives.  起草年度物料和供应商管理回顾报告。 Draft annual review report of material and supplier management.  协调供应商相关偏差、变更、供应商质量投诉调查,确保纠正和预防措施的有效执行和记录。 Coordinate supplier related deviation investigation, change control and supplier complaint investigation, ensure the effective execution and record of corrective and preventive actions.  参与官方/客户审计。 Participate in regulatory/customer audit.  负责供应商审计,起草、审核供应商审计计划和报告。 Be responsible for supplier audit, and draft and review supplier audit plan and report.  负责供应商管理相关程序文件的起草、更新和审核。 Be responsible for the supplier management procedures drafting, revision and review.  完成主管安排的其他工作。 Jobs assigned by the supervisor.

任职要求

  • 药学或化学相关专业,本科以上学历。
  • Major in Pharmacy or chemistry, bachelor degree or above.
  • 了解制药生产、检测和质量管理,熟悉GMP相关法规。
  • Knowledge of pharmaceutical manufacturing, testing and quality management, familiar with GMP regulations.
  • 英文水平良好
  • Good English skills
  • 计算机良好
  • Good computer skills
  • 一年以上药厂或相关领域质量管理相关经验
  • More than 1 year of experience in pharmaceutical or related field quality management
  •  较强的沟通协调能力
  • Strong coordination and communication skills
  •  较强的问题调查能力和逻辑判断能力
  • Strong problem investigation ability and logical judgment ability

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