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• Ensure that all validation activities are in compliance with China GMP, cGMP, cGLP, QSR (including Design Controls), ISO or other applicable requirements.

确保验证活动符合China GMP，cGMP，cGLP，QSR（包括设计控制），ISO或其它适用的要求。

• Determine scope and strategy for validation. Drafting Validation Master Plan for site and project.

确定验证的范围和策略。 编写工厂/项目验证主计划。

• Generation and execution of qualification/validation protocols（IQ/OQ/PQ）, including but not limited to equipment qualification, process validation, etc.

编写和执行确认/验证方案（IQ/OQ/PQ），包括但不限于设备验证，工艺验证等。

• Be responsible for facilities/utilities validation, such as clean HVAC system, compressed air system, purified water system, water for injection system, etc.

负责公用设施验证，例如洁净空调系统，压缩空气系统，纯化水系统，注射水系统等。

• Serve as site validation representative on cross functional teams for transfer, NPI and other projects as necessary including supervision of contract validation resources.

作为跨职能团队的验证代表，负责转移、新产品导入和其他必要的项目，包括监督合同验证资源。

• Generate and manage validation procedures, such as Process Validation Procedure, CSV Procedure, etc.

编写和管理验证程序文件，例如过程验证流程，计算机软件验证流程。

• Support China GMP, FDA inspections, ISO certifications, surveillance audits and customer audits。

支持中国GMP、FDA检查、ISO认证、监督审核和客户审核。

• Other work assigned by supervisor.

主管安排的其它工作。

Unsolicited Agency Submission

Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate's name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.