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验证工程师

A career at Merck 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 electronics. For more than 352 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:

Overall job purpose:

Provide quality oversight to Computerized System and Data Integrity to ensure all the activities within the life cycle of the Computerized System and Data Integrity are compliance with LS quality standards and customer expectations.

Responsibilities:

Computerized System Life Cycle Management: (80%)

  • Establishing management system for the life cycle of the computerized system and GMP Data.
  • Working closely with Validation Group, System Owner and Business Owner to achieve and maintain Computerized Systems and Data Integrity compliance.
  • Lead/organize/support of resolving all issues related to Computerized Systems and Data Integrity compliance during routine quality operation, internal/external audits and self-inspections.
  • Conduct assessment to new computerized system and determine validation strategy, establish validation requirements based on established SOPs and local standards to ensure compliance and maintain an inspection readiness state.


SU center IT projects CSV management: (20%)

  • Participate SU Center IT project as CSV/DI Expert role, and work into developing, reviewing, and managing CSV activities (SAP/EBR/QIBS/WMS/TMS/WCS/BMS/EMS) , and ensuring that the validation activities meet with LS CSV and DI requirements.

 

Who you are:
Skills, Performances & Competences required by the position:

  • BS or above in Life Science/Pharmaceutical/Computer or equivalent.
  • 5+ years’ experience in Quality/Technical/Operation in pharmaceutical, medical device, or life science industry.
  • Familiar with GMP/ISO and quality management.
  • Fluent in English.
  • Result orientation, accuracy and reliability as a must.
  • Excellent communication, problem-solving, planning and organization skills.
  • Site expansion/tech transfer projects experience, or CSV of medical device/filter/Single Use products preferred.

 

HR: 95989

Functional Area: Quality

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

Job Requisition ID:  252768
Location:  Wuxi
Career Level:  D - Professional (4-9 years)
Working time model:  full-time

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our Candidate Services team at 844-655-6466 from 8:00am to 5:30pm ET Monday through Friday. If you are a resident of a Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request.  You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.

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