Quality Assurance Specialist

Posted 19 May 2022

Shanghai, Shanghai - China

Req Id 244732

Details

 

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.

 


Job Description

 

Scope of Responsibility: Contributes to or impacts the results of the Quality Assurance (QA) team and is accountable for the quality of own work. Receives clear instruction, guidance and direction from more senior level roles or solves problems of low complexity independently by identifying and selecting solutions and by analyzing information.

 

Your role:

The individual performs a variety of tasks within the Quality Assurance department including conducting audits and review / approval of various types of regulated documentation.

 

Essential Job Functions:

  • Support the organization with the establishment of quality systems & support appropriate training for the new PSS facility in China.
  • Review and approve standard operating procedures (SOPs), laboratory / batch records and other quality records.
  • Review and approve study files against regulatory and internal requirements to include protocols, technical specifications, raw data, final reports, cell banking production records, and certificates of analysis.
  • Review and approve validation files for systems and assays.
  • Review and approve deviation records.
  • Conduct laboratory inspections.
  • Liaise with global counterparts as needed.

 

Who you are:

Education and Experience:

  • Graduate degree in life sciences or higher related degree
  • Minimum of 4 – 5 years' experience in Quality Assurance or related field within a GxP environment.

 

Competencies:

  • Acts ethically and ensures quality of own work and that of others.
  • Takes responsibility for ensuring that turnaround times are met.
  • Works with cross-functional teams and builds networks within QA and Operations departments.
  • Open-minded, flexible and works with agility.

 

 

Knowledge and Skills:

  • Fluent in both written and spoken Mandarin
  • Fluent in both written and spoken English
  • Basic knowledge of FDA regulations (21 CFR Parts 11, 58, 210, 211 etc.) and China regulations.
  • Familiarity with International regulations (EMA, MHRA).
  • Strong oral and written communication and interpersonal skills required.

 

HR: 89829

Functional Area: Research & Development

 

 

 

 

 

 


 

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!

 

Curious? Chat with one of our curious minds on our interactive Q&A platform and catch a glimpse of our people, values, and culture. You can also apply and find more information at https://jobs.vibrantm.com

 

If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.merckgroup.com/en/company/press-positions.html

Apply Now