R&D Quality Document Management Specialist
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.