R&D Quality Document Management Specialist

Hydrogen Group · Firenze, Italy Metropolitan Area, Italia ·


Descrizione dell'offerta

We are supporting our client in seeking an experienced R&D Quality Document Management Specialist to join their Quality Systems team supporting pharmaceutical R&D operations.


Key Responsibilities:

  • Manage the full document lifecycle: creation, review, approval, distribution, archiving.
  • Ensure controlled documents meet internal and regulatory requirements.
  • Maintain and administer the eDMS (e.g., Veeva Vault, MasterControl) and support system validation and change controls.
  • Train and support staff on document management policies, procedures, and tools.
  • Prepare documentation for audits and respond to internal and external stakeholder requests.
  • Continuously improve document control processes and contribute to Quality Systems metrics and reporting.


Requirements:

  • Bachelor’s degree in Life Sciences, Quality, Information Technology, or related field (or equivalent experience).
  • Minimum of 3 years’ experience in document management, quality systems, or quality assurance in a regulated (pharma/biotech/medical device) environment.
  • Strong knowledge of GxP and regulatory guidelines.
  • Experience with eDMS platforms (Veeva Vault is a must ) and document control best practices.
  • Excellent organizational, communication, and interpersonal skills.
  • Fluency in Italian and professional level English skills.

Candidatura e Ritorno (in fondo)