Senior Validation Specialist

Posted 14 Jan 2019

Shanghai - all, Shanghai - China

Req Id 185442

Details

A career  is an ongoing journey of discovery: our 52,000 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.

 


Your role:

Within E2E APAC, the senior validation specialist will work directly with operation teams and other quality team members. Within Merck, the senior validation specialist will work with other necessary teams including but not limited to Technology, Field Service, Regulatory, and overseas global quality teams. The primary responsibility of this position is ensuring the delivery of all validation relevant works.

2. Main Responsibility

  • Establish, maintain and update QDS relevant to validation, calibration and maintenance.
  • Participate and manage GMP validation project in a risk-based manner. Establish on-site QPP for validation project.
  • Prepare and update site VMP and trace validation execution status in terms of VMP.
  • Manage SAT and FAT activities.
  • Review validation related documents (SIA, URS, DQ/IQ/OQ/PQ protocols, records and reports) including but not limited to equipment, utility, analytical method, cleaning, production process and transportation.
  • Manage outsourced validation team and support validation implementation. Coordinate involved departments in validation activities
  • Overall management of calibration and maintenance. Establish schedule and inform operation team before due date. Review and archive relevant documents.
  • Ensure compliance and data integrity during all activities of validation, calibration and maintenance.
  • Maintain validation, calibration and maintenance databases to ensure timely update.
  • Lead and act as the Subject Matter Expert of validation for routine quality operation, internal/external audits, health authority inspection and client communication.
  • Provide regulatory support in field of validation as per the request of customer or colleagues.
  • Accomplish other tasks assigned by line manager.
  • Respect and follow EHS rules.

Who you are:

Education

  • Bachelor degree or above
  • Major in Pharmacy, Biotechnology, Engineering, Life science or related backgrounds

Required Experience

  • Minimum 5 years working experiences in field of validation in pharmaceutical industry or third party.
  • Solid knowledge of cGMP, FDA, EMEA, ASME, and national standards relevant to validation.
  • Rich experience in green field projects.
  • Familiar with pharmaceutical facilities, utilities and equipment.

Preferred Experience

  • Knowledge of antibody production process
  • MNC or third party working experience
  • Knowledge of handling validation instruments.

Language Skill

  • Fluent English speaking, reading and writing
  • Good technical writing skills in English is a plus

HR 89831

Functional area: Quality


 

What we offer:  there are always opportunities to break new ground. We empower you to fulfill 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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