天津招聘

职位描述：

A career at Merck is an ongoing journey of discovery: our 50,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

Overall job purpose/工作目标概括：

• This position will assist in setting up validation program for the project, preparing validation/qualification procedures, and protocols/reports, to ensure the project and future operation are in compliance with all Domestic and Global regulatory and corporate requirements.
  

  该职位协助设定项目验证程序，起草验证/确认规程、方案/报告，以确保项目及未来运行符合国内外法规和公司要求。

Responsibilities/工作职责：

• Assist to develop site validation and qualification program. The main responsibility includes:
  

  协助开发工厂验证和确认程序。主要职责包括：

• Prepare and update site validation master plan.起草并升级工厂验证总计划。


• Prepare validation and qualification related SOPs.起草验证和确认相关的SOP。


• Define specific validation and qualification strategy by preparing validation plan for facility, equipment, manufacturing process, cleaning procedure and computerized system.
  

  起草厂房设施、设备、生产工艺、清洁程序和计算机化系统验证计划以定义详细的验证和确认策略。

  
  
  

• Participate validation and qualification activities in the plant which includes:
  

  参与工厂的验证和确认活动，包括：

• Participate in risk assessment of process equipment, utility, manufacturing process, cleaning procedure and computerized system.
  

  参与工艺设备、公用系统、生产工艺、清洁程序和计算机化系统风险评估。



• Prepare Commissioning & Qualification protocol and report equipment and utility.起草设备和公用系统调试和确认方案和报告。


• Review the qualification documents provided by vendor.审核供应商提供的确认文件。


• Prepare the process validation/cleaning validation/computerized system validation protocol and report.起草工艺验证/清洁验证/计算机化系统验证方案和报告。


• Be involved in qualification and validation execution.参与执行确认和验证活动。

• Track project and site validation activities, ensure all the validation activities included in VMP are implemented in time.
  

  追踪项目和工厂验证活动，确保VMP中的所有验证活动及时执行。



• Archive validation documentation
  

  归档验证文件

Skills, Performances & Competences required by the position:

岗位所需技能，绩效及能力:

• BS in Pharmaceutical or equivalent.制药或同等专业本科学位。


• 3-5 years’ validation experience in pharmaceutical plant.制药行业3-5年验证工作经验。


• Familiar with GMP and quality management.熟悉GMP和质量管理。


• Experience and knowledge in validation and qualification.具有验证和确认的经验及知识。


• Fluent in English.英语流利。


• Result orientation, accuracy and reliability as a must.必须的结果导向、准确性和可靠性要求。

• Excellent communication, problem-solving, planning and organization skills.优异的沟通、解决问题、计划和组织能力。

What we offer: At Merck, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at come2merck.com

举报 分享

默克雪兰诺有限公司
默克雪兰诺是总部位于德国达姆施塔特的全球医药和化工集团默克公司旗下生物制药业务分支。默克雪兰诺总部设在瑞士日内瓦，致力于发现、开发、生产和销售针对特定适应症的化学和生物的处方药。北美业务在美国和加拿大以EMD 雪兰诺的名称运营。

默克雪兰诺中国总部位于北京，拥有员工约1200人，业务遍及全国。目前，默克雪兰诺在中国经营9个领域18种药品，在未来几年里，还将上市多种新药。