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GCP Clinical Auditor at Global CRO Start-up (Fully Remote)

Remote: 
Full Remote
Contract: 
Salary: 
4 - 4K yearly
Experience: 
Mid-level (2-5 years)
Work from: 

Offer summary

Qualifications:

University degree in a scientific field, High fluency in English and Japanese, Experience conducting GCP audits independently, Familiarity with local regulations, Ability to travel for remote audits.

Key responsabilities:

  • Conduct onsite and remote GCP audits
  • Prepare audit documents and reports
  • Support inspection preparation and mock inspections
  • Project manage audit programs and system reviews
  • Perform QMS gap analysis
Michael page logo
Michael page Human Resources, Staffing & Recruiting Large https://www.page.com/
5001 - 10000 Employees
See more Michael page offers

Job description

Logo Jobgether

Your missions

  • Innovative global start-up CRO specializing in oncology and rare disease|Lead in GCP audit activities for the business to ensure effective compliance


About Our Client

  • Globally established business entering the Japan market
  • Partnering with over 100 active clients with track record of working with over 700 pharmaceutical companies
  • Business specializing in GxP services for compliance in local/global regulations for oncology and rare disease therapeutic areas
  • International company culture working with extensive collaboration with external stakeholders
  • Fully remote working style (can consider anyone in Japan)


Job Description

  • Conduct onsite and remote audits for GCP of investigator sites, system audits for sponsors, vendors, and services providers (Average 2 audits per quarter)
  • Prepare, conduct, and report effective GCP audit documents, TMF audits, and data base audits
  • Support inspection preparation audits as well as mock GCP inspections that align with local regulations (PMDA), ICH GCP guidelines that are applicable to the FDA/EMA
  • Project manage audit programs and deliver guidance for system reviews, QMS gap analysis


The Successful Applicant

  • University degree in a scientific or related field
  • High fluency in English and Japanese (non-native level speakers will not be selected)
  • Track record and experience of conducting/leading GCP audits independently
  • Exposure to conducting GCP mock inspections and well conversed in local regulations
  • Ability to travel to conduct remote audits


What's on Offer

  • Competitive salaries and benefits
  • Fully remote working style (can consider anyone in Japan)
  • International working environment, part of the global GCP audit organization
  • Amazing career progression in GCP QA
  • Work with industry leaders who are solving various unmet medical needs


Contact: Zach Itozu

Quote job ref: JN-092024-6522733

Required profile

Experience

Level of experience: Mid-level (2-5 years)
Industry :
Human Resources, Staffing & Recruiting
Spoken language(s):
Check out the description to know which languages are mandatory.

Soft Skills

  • Verbal Communication Skills
  • Detail Oriented
  • Analytical Thinking
  • Collaboration

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