VIE - Quality & Regulatory Assurance Coordinator

4 weeks ago

Bridgewater, United States EuroAPI Full time
We are looking for a VIE - Quality & Regulatory Assurance Coordinator for a VIE contract of 18 months in our US site in Bridgewater to support its activity.

Before applying, please make sure to check the VIE eligibility criteria for the United States and add your resume in English to your application.

Your responsibilities:

Customer Request & Complaints:
  • Collect, handle and follow-up on customer requests and complaints
  • Coordinate investigation work on deviations and non-conformities in cross-functional teams
  • Initiate and assure the follow-up of open CAPA (Corrective Action Preventive Action)

Regulatory Dossier Management
  • Track, Monitor and support Change Control (CCAF) and its proper review
  • Contribute to regulatory assessment projects for specific client needs
  • Participate in client meetings

Quality & Regulatory Management Framework:
  • Participate in the continuous improvement of the Quality & Regulatory Management Systems
  • Participate to the update of the Standard Operating Procedures
  • Ensure compliance of product shipments with regulatory standards (FDA, EMA, ICH, ISO...)
  • Ensure proper recording of all QARA activities in global tracking & reporting systems

Your profile:
  • Master's degree in Quality Management, Quality Engineering or Regulatory Affairs
  • 2-3 years of professional experience (experience in pharma is a plus)
  • Good understanding of Global Quality & Good Manufacturing Practices (GMP) standards
  • Basic understanding of North America Health Rules & Regulations (ex: FDA guidelines)
  • Strong data analytics skills and ability to manage large volume of information
  • Excellent project management skills and analytical skills
  • Demonstrates ability for teamwork and interaction with multiple stakeholders
  • English is mandatory and French is a plus

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