Freelance GMP Consultant

at

ProPharma Group

Leiden, Netherlands
Full Time
4mo ago

Company Description

ProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, and the United States, ProPharma Group’s fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today’s dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.

Job Description

We are looking for a freelance GMP consultant, expert Chinese GMP regulations who can support us with one of our projects. This is a freelance remote long term project requiring 1-2 days per week availability.

Essential Functions Include:

  • Subject matter lead for GMP auditing projects within ProPharma Group. 
  • Analyze the root cause of issues with Chines Health Authorities
  • Insight into new Chinese pharmacopeia and other apparent regulations and expectations
  • Final review of CAPA resolution 

Qualifications

Qualified candidates must have:

  • B.S./B.A in scientific discipline as a minimum.  A graduate degree in a scientific discipline is preferred.
  • Senior GMP consultant.
  • Expert in CFDA GMP regulations.
  • Deep understanding of Chinese GMP regulations and proven experience with interacting with Chinese Health Authorities.
  • Ability to interact in a professional and positive manner with clients and co-workers. 
  • Exceptional communicator with strong persuasion skills and presentations.
  • Excellent interpersonal and communication skills.
  • High level of understanding of the criteria for selection for supplier management and GMP auditing services in the pharmaceutical, medical device and biotech industries. 
  • Ability to read, prepare and analyze data for the development of reports; ability to sit and type for long periods of time; ability to read and assemble documents as required.
  • Fluency in English and Mandarin.

Additional Information

All candidates must be legally eligible to work in the European Union.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***

 

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Onkar By: Onkar