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Sr. Quality System Specialist

Posted 17 Oct 2017

Nantong, Jiangsu - China

Req Id 166091

Details

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.


Job Description:

Purpose of the role

Build up and maintain sustainable quality system based on MBQ standards and with the local GDP (GSP) / GMP.

Functional Tasks

  • Following good documentation practice to build up and maintain sustainable quality system, guide and supervise the implementation, to ensure Nantong logistics center complies with local GDP (GSP) / GMP requirements and global quality standards.
  • Responsible for drug business related license application and renew.
  • Collect and analyze quality information, monitor the implementation of related laws and regulation in concerned departments and positions.
  • Responsible for change control management.
  • Organize the preparation of monthly quality report (Tier 1 report) and quality management review.
  • Organize quality risk management, carry out continual improvement on quality system.
  • Responsible for quality query and the investigation, handling, report of quality complaint.
  • Report counterfeited product.
  • Support DS to conduct safety events of drug reporting and monitoring.
  • Assist to carry out the education and training in quality management field.
  • Act as local leader user of Trackwise system.
  • Supervise the health of personnel directly contacting with drug.
  • Responsible for recall and alert management.
  • Manage CAPA.
  • Coordinate health authority inspection.
  • Coordinate self-inspection and internal audit.
  • Support distributor qualification and audit.
  • Review and approve finished goods license and distributor related license in SAP and GTS.
  • Other duties as assigned by supervisor.

 

Job Requirements:

  • Good English skill at reading, writing,listening and specking.
  • Bachelor degree or above in pharmacy,biology,chemistry,medicine or other related area.
  • Licensed Pharmacist.(Mandatory)
  • Above 3 years quality experience in GMP or GDP (GSP) area
  • Willing and able to travel at least 30% of the time.

HR 87157


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

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