Warehouse Compliance Specialist

GE HealthCare · Shanghai

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Job Description Summary

Job Description

Responsible for warehouse GMP compliance, quality system maintenance, document management, and employee training to ensure warehouse operations comply with company Quality Management System (QMS) requirements and applicable regulations. The role also supports SAP goods receipt activities and warehouse operational processes to ensure inventory accuracy and operational efficiency.

负责仓库GMP合规管理、质量体系维护、文件管理及员工培训工作，确保仓库运营符合公司质量管理体系和相关法规要求。同时兼顾SAP系统收货操作及相关运营支持工作，保障库存数据准确及仓库运营高效有序。

Roles Responsibility :

职责：

1.    Training Management 部门培训管理

• Ensure that all the trainings of warehouse are carried out according to procedures.
  确保仓库所有的培训根据需要已执行。
• Ensure that the training records are up to date.
  确保及时更新培训记录。
• Ensure all CV and JD is up to date.
  确保及时更新个人履历表和岗位说明书。
• Assist warehouse manager to prepare a yearly training plan to all employees and ensure its execution.
  协助仓库经理准备年度培训计划并确保其执行 。

2.    GMP Compliance & Quality Management GMP合规及质量管理

• Ensure warehouse operations comply with GMP requirements and company quality standards.
• 负责仓库GMP要求的落实和日常监督。
• Follow up all warehouse observations/deviations from internal/external audits, make sure the timely closure of deviations, CAPA and change controls.
  追踪在内部/外部审计中发现的缺陷/偏差, 确保偏差, CAPA和更改控制的及时完成。
• Prepare, review, revise, and maintain warehouse SOPs, work instructions, forms, and quality records.
• 负责仓库SOP、工作指导书及质量记录的编制、修订和维护。
• Monitor compliance status within warehouse operations.
•  管理仓库文件归档和版本控制。
• Support QA in deviation investigations and risk assessments.
• 协助QA进行质量事件调查和风险评估。
• Support Warehouse Quality improvement, Productivity improvement and Lean projects.
• 参与仓库质量改进、生产效率改进、精益项目。

3.    Operational Support运营支持

• Support Goods Receipt (GR) transactions transactions when required.
  根据业务需要协助SAP系统相关收货事务处理。
• Perform other duties as assigned by management.
• 完成管理层安排的其他工作。

Qualification/Requirements:

资质/经验

• Bachelor's degree or above, Major in Pharmacy, Pharmaceutical Engineering, Quality Management, Supply Chain, Logistics, or related disciplines preferred.
• 本科及以上学历，药学、制药工程、质量管理、物流管理等相关专业优先。
• Major in Pharmacy, Pharmaceutical Engineering, Quality Management, Supply Chain, Logistics, or related disciplines preferred.
• 药学、制药工程、质量管理、物流管理等相关专业优先。
• 2 year of experience in pharmaceutical industry QA, Quality Systems, Warehouse Quality, or GMP Compliance
• 2年以上药企QA、质量体系、仓库质量或GMP合规经验。
• Fluent in written and oral English, CET-6 or equivalent
• 英语书面和口语流利, 大学六级或相同水平级别

Desired Characteristics:

期望特质

• Strong commitment to quality, compliance, and patient safety.
• 具备强烈的质量意识、合规意识和患者安全理念。
• Excellent communication and interpersonal skills with the ability to engage effectively at all organizational levels.
• 具备优秀的沟通协调能力，能够与各层级同事有效合作。
• Strong organizational skills with attention to detail and a high degree of accuracy.
• 组织能力强，关注细节，数据和文件处理准确严谨。

Inclusion and Diversity

GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

Behavior Statement 

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership always with unyielding integrity.

Total Rewards Statement

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

Additional Information

Relocation Assistance Provided: No

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