药明康德
供应商管理QA(J25243)
岗位职责
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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