北京招聘

Responsibilities
QA Operations FDA cGMP/SFDA GMP manufacturing facility compliance supporting the following groups/processes: Development, Validation, Maintenance, Calibration and In-Process QA Inspection of Product. QA运作使cGMP/GMP生产设施合规以支持如下团队/流程：开发，验证，维护，校验，产品进程内的QA检查。
Release or Reject Raw Materials, Components, In-process Materials, Bulk Products and Finished Products.原辅料、包材、中间体、大包装产品和成品的放行或拒绝。
Support and management for internal/external auditing, and supplier qualification system.
支持和管理内部/外部审计，以及供应商确认体系。
Direct QA auditing activity support for the following teams/processes: Development, Validation, Maintenance, training. Reporting, tracking and follow-up of deficiencies / CAPAs noted.
指导QA审计活动以便支持如下的团队/流程：开发、验证、维护、培训、提供持续的生产审计支持、质量体系和/或合规审计、报告、追踪偏差/纠正预防措施。
Management of QA Team members QA团队成员的管理
Oversight and management / maintenance of cGMP manufacturing and/or manufacturing related documentation integrity for executed Quality Records 监督和管理/维护cGMP生产和/或执行质量记录的生产相关的文件完整性。
Participation in and/or management of Operational / Operations related Quality Systems Improvement Projects as assigned参与和/或管理运营的/运营相关的提高质量体系的计划。
Work directly with the QA Supervisor, monitor/follow-up and facilitation of action items relating to cGMP compliance quality problem investigations. Work with and support operations team members with facilitation / monitoring status of timely processing on action item activity to closure for all operations compliance / related activity. 与QA主管紧密工作以指导/追踪，和促进cGMP合规质量问题相关的调查。与运营团队合作以及支持其成员能促进/监督及时处理所有运营合规/相关活动的行动项。
Responsible for the FDA cGMP & SFDA GMP compliance training for operations and operational support groups/teams. And, overall A team member development. 对运营以及运营支持团队/组进行cGMP/GMP合规培训。同时，提高QA团队成员的发展。
Assist management with participation in on-site regulatory agency and/or compliance audits. Primary Quality Contact for sFDA inspection-related activities.
协助管理层参加现场法规机构和/或合规审计。担任sFDA法规检查相关活动的主要质量联系人。
Other related duties as assigned by supervisor. 主管分配的其他相关任务

Requirement
Experience in the management of, development of and motivation of a multi-level-skilled QA Team in Team based environment. 在团队环境中，拥有管理，发展以及激励多层次技能的QA团队
Good working knowledge of USFDA cGMP & SFDA GMP Manufacturing Regulations for Pharmaceutical products. 对药品生产USFDA cGMP 和中国SFDA GMP法规良好的工作经验与知识。
Solid compliance leadership and team mentoring skills, demonstrated by the ability to influence decisions, build consensus, plan, organize and communicate in a dynamic cross-functional environment. 优秀的合规领导力和团队指导技能，能表现出在决策中的影响力，以及在一个动态跨部门的环境中计划，组织，交流和达成一致的能力。
Solid problem solving skills. (i.e., ability to Compile, Analyze and Recommend appropriate C/A) 优秀地解决问题的技巧（例如，有编辑，分析的能力，以及推荐适宜人选的能力）
Time Management / Organizational skills良好的时间管理/组织能力
Attention to detail and ability to follow-through on commitments.
关注细节，并能持续跟进承诺。

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