Qualification Specialist

Posted 25 Sep 2019

Nantong, Jiangsu - China

Req Id 197702


A career is an ongoing journey of discovery: our 51,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

Your role

  • Develop project & site validation master plan, in terms of Utility, Facility, Equipment, Process, Cleaning, CSV, etc. validation and qualification strategy. Lead, organize and monitor the execution, ensure the health status of each systems.
  • Develop site qualification program and prepare qualification related SOPs.
  • Participate qualification activities in the plant which includes:
  • Participate in risk assessment of process equipment, facility and utility.
  • Review the commissioning & qualification documents provided by vendor.
  • Prepare Qualification protocol and report for equipment and utility.
  • Be involved in qualification execution.
  • Track project and site validation activities, to ensure all the validation activities included in VMP are implemented in time.
  • Conduct additional task assigned by company, as necessary.


Who you are

  • BS in Pharmaceutical or equivalent.
  • At least 3 years’ validation/qualification/production/engineer experience in pharmaceutical plant, has basic knowledge on utility/process equipment.
  • Familiar with GMP and quality management.
  • Fluent in English.
  • Result orientation, accuracy and reliability as a must.
  • Excellent communication, problem-solving, planning and organization skills.


HR 95592

Functional area: Quailty

What we offer: 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!

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You have accessed https://www.emdgroup.com, but for users from your part of the world, we originally designed the following web presence https://www.merckgroup.com.

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