质量审核员岗位职责

供应商质量审核员 Develop, implement, and ensure understanding and compliance to all SOPs with respect to raw material approval process and supplier qualification process;

开发、实施并确保理解和遵循所有原材料审批和供应商批准的标准操作规程;

Audit all new and existing high risk suppliers to ensure compliance to XXX Quality standards;

审核所有新供应商和现有高风险供应商,确保符合XXX质量标准;

Liaise with the Supply Chain to ensure internal and customer QA requirements are fulfilled (procurement, PSM, commercialization, customer service, sales, logistics, etc.) for suppliers and raw materials;

联系供应链,确保供应商和原料满足内部和顾客的质量要求;

Liaise with Regulatory to ensure suppliers and ingredients meet regulations for the country of sale;

联系法规部门,确保供应商和原料满足销售国的法律法规;

Evaluate all required documents received from suppliers and conduct Risk Assessment for all new suppliers and raw materials prior to commercialization;

评估供应商提供的所需文件并在批准新供应商和原料前实施风险评估;

Responsible for handling and resolving material deficiency reviews (MDR) and non-conformance reports for all ingredient used in manufacturing XXX products;

负责处理和解决原料的异常和生产过程发现的不符合报告;

Manage and complete all customer requests regarding documentation and questionnaires for suppliers and ingredient raw materials;

管理和提供顾客需要的跟供应商和原料相关的文件和问卷;

Provides training on quality principles, application of procedures and quality improvement techniques;

提供适当的质量原理,程序应用和质量提升技能的培训;

Review Raw Material documentation and assign approval status on approval forms;

审查原料的文件并签署批准单;

Perform other duties as assigned or needed.

必要时,完成其它安排的工作。 需要国内出差,50%左右