资深质量专员

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Date: Nov 11, 2022

Location: Shanghai, Shanghai, CN, 201203

Company: Merck KGaA Darmstadt, Germany

 

A career at our company is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. 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: To ensure QMS of local subsidiary is in compliance with requirements of ISO 9001/GDP standard as well as Company Internal Procedures. Support or lead the new project from local distribution and subsidiary in quality perspectives. To act as Quality Representative or Quality Delegator for maintaining Quality Management System (QMS) of local Distribution warehouses.

 

  1. To facilitate ISO9001: 2015 group certification and Life Science divisional audits according to relevant standards for local subsidiary and distribution centres. To organize internal audit/ self-inspection as lead auditor for departments/ functions involved in local business. Follow up audit reports and CAPA actions accordingly.  

 

  1. To lead planning, implementing and review of Quality Management Systems (ISO 9001 standard) in cooperated Quality Management level meeting divisional standard/ requirements, as well as, fitting daily operation of local distribution and commercial subsidiary.

 

  1. Be responsible for Quality Management Review of local subsidiary following Life Science guidance. To coordinate internal customer advocators and stakeholders in quality-related clauses review of commercial contract and local customer statement.

 

  1. To support quality activities in local Distribution Centre engaging in participate related quality activities (e.g. complaint, deviation, CAPA, risk management, quality data review, pest control management, etc.).

 

  1. To monitor all Key Quality Indicators and related CAPAs are closed within defined due date and its effectiveness are well validated.

 

  1. To act as a country key user of e-Quality systems (e.g. TrackWise):
    • Conduct introduction training and grant access to end uses
    • Communicate and implement necessary changes and business process policy
    • Performance Monitoring and Involvement for critical case.

 

  1. To implement continuous quality improvement and risk mitigation with local distribution and commercial teams as a business partner. To prompt quality culture and awareness of internal and external stakeholders involved in local distribution processes on a regular basis.

 

Who you are:

 

  1. Bachelor’s/Master’s degree in chemistry, bio-science, pharmaceutical or related filed.
  2. 6 years+ experience in quality assurance of Life Science, Pharmaceutical, or equivalent experience.
  3. Fluency in English, both oral and written.
  4. Be familiar with quality system such as ISO 9001 and GDP.
  5. Strong organization, communication and teamwork skills to interact within cross functional groups.
  6. Proficient in MS Office Software (Word, Excel, PowerPoint, Project).

 

HR: 89831

Functional Area: Quality Assurance


What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology. We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!
 


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