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Quality Assurance and Regulatory Affairs Specialist

Il y a 3 mois


Aubenas, Auvergne-Rhône-Alpes, France PHARMAXYOM Temps plein

Quality Assurance and Regulatory Affairs Specialist

Company Name: PHARMAXYOM

Overview:

In this role, you will oversee the quality assurance and regulatory affairs initiatives.

  • Ensure adherence to quality protocols and regulatory standards.
  • Incorporate product quality specifications into the organization's Quality Management System.
  • Lead specific projects aimed at enhancing quality.
  • Track quality incidents and execute corrective action plans.

Serve as the primary quality liaison across various departments.

Engage in product risk assessments.

Attend site meetings focused on product workflows.

Conduct audits and improve product quality methodologies.

  • Oversee regulatory affairs processes.
  • Prepare necessary documentation for regulatory filings.
  • Participate in site evaluations.

Candidate Profile:

A Bachelor's degree in scientific or regulatory affairs is required.

Extensive experience within the pharmaceutical sector is essential.

Demonstrated strong interpersonal abilities, practical approach, and collaborative spirit.

This is a full-time opportunity based in the Southern region.