in accordance with approved procedures and in compliance with current GMP requirements Performs the QA review and approval of the...
is manufactured according to approved procedure and in compliance with current GMP requirements Performs the QA review and approval...
in the QA department, you will be responsible for EHS tasks and Quality management and manage EHS activities under Wabtec...
Welcome to Haleon. We’re a purpose-driven, world-class consumer company putting everyday health in the hands of millions. In just three years since our launch, we’ve grown, evolved and are now entering an exciting new chapter – one filled w...
Major responsibilities Facility & Utilities Qualification (URS/DQ/IQ/OQ/PQ): Coordinate qualification of cleanrooms (ISO classes), HVAC, process gases, and PW/PS systems; ensure environmental monitoring programs are defined and validated....
Welcome to Haleon. We’re a purpose-driven, world-class consumer company putting everyday health in the hands of millions. In just three years since our launch, we’ve grown, evolved and are now entering an exciting new chapter – one filled w...
责任描述和工作范围 组织、建立新厂房的质量管理体系的建立，包括： 跟进并协调新厂房GMP质量体系的建立，并与已有质量体系协调一致； 作为文件管理员审核GMP文件，组织、协调各部门文件管理员对各类文件和记录的发放、回收、归档、销毁工作进行控制和管理，确保符合SOP要求； 负责批记录的发放； 负责档案的借出、归还和管理，管理档案室。 组织、建立和维护培训要求： 组织、协调各部门培训管理员建立和维护员工培训矩阵，审核培训材料； 引导新员工的入职培训； ...
职位概述(岗位设置的目的、目标、权限等)： * 质量体系的管理与维护 新项目导入质量保证的符合性 审核与内部培训 工作职责(按重要性顺序列出)： * 药包材生产质量管理体系的维护，包括:实施与持续改进，确保质量管理体系符合适用法规要求（如药包材GMP），行业标准（如ISO 13485、ISO 15378）要求。 负责编制及修订质量管理体系文件，包括程序文件、作业指导书及记录表单等，确保文件满足法规及Aptar集团要求（根据产品的应用进行流程差异化管理）。 负责新...
and supplier audits together with QA Engineer regarding quality, cost, delivery and service. Develop and manage vendor...
, Organizational Project Management, Problem Solving, Project Engineering, Quality Assurance (QA), Regulatory Compliance, Relationship...
to the supervisor or QA. Support company clinical research and regulatory submissions (including China–U.S. projects...
to the supervisor or QA. Support company clinical research and regulatory submissions (including China–U.S. projects...
解决方案并汇报生产运营团队。与 PE/AE 合作解决问题。 Cooperate with zero loop team (Operators, maintenance specialist, QA, etc) to implement actions.... Ensure clear shift hand over with zero loop and operations team members. 与一线团队（操作员、维护专员、QA 等）跨部门合作，完成行动项。确保...
supervisors, laboratory inspectors, QA, and other stakeholders to promptly resolve on-site quality issues. What you´ll...
-disciplinary team (product management, design, QA, operations) to participate in requirements analysis, technical design, code...
and external standards. Will work within the QA Shared Services Product Transfer Team, responsible for quality related activities...
, mocks, and test utilities to support both API and end-to-end testing. Collaborate with developers, product owners, and QA...
, design, interfaces, risk controls) and support design transfer. Collaborate with Product Owners, QA/RA, Clinical...
, interfaces, risk controls) and support design transfer. Collaborate with Product Owners, QA/RA, Clinical, and Operations...
or Chemistry Required Experience -生物/化学或相关科学本科学历； -在 GMP 环境中QA/质量部门的至少 5 年的工作经验； -有客户审核、第三方审核机构和许可机构的审核经验者优先考虑； -熟悉ISO13485...