R&D Admin & cGMP Compliance Specialist

PCI Pharma Services; León; Presencial; EUR 26.000 - 38.000; Jornada completa

Descripción de la vacante

PCI Pharma Services is seeking an organized administrator to support R&D documentation and data management in a fast-paced pharmaceutical development environment. The role focuses on document control, data reporting, and change control coordination within cGMP guidelines.

The candidate will handle templates, forms, and records, collaborate with multiple departments, and support onboarding and training documentation as part of ongoing process improvements.

Formación

• Knowledge of cGMP documentation practices and document control systems is desirable.
• Ability to manage multiple administrative tasks with high accuracy.
• Professional integrity and respect in interactions with colleagues.
• Experience with pharmaceutical development processes is a plus.
• Creative with minimal supervision and independent thinking.
• Resilience through organizational change and fast-paced environments.

Responsabilidades

• Document Management and Control – Organize, scan, archive, and maintain R&D department documentation; ensure traceability and template management.
• Documentation Issuance – Generate and issue forms, templates, labels, logbooks, and documentation for R&D trials and related activities.
• Data Management and Reporting – Create and update departmental databases and tracking tools; prepare charts and reports.
• Change Control Support – Coordinate basic document-related change controls and support updates with project teams.
• Protocol and Report Preparation – Prepare simple protocols, reports, and controlled documents using approved templates.

Conocimientos

Strong organizational skills

Attention to detail

Communication skills

Educación

Associate Degree or Bachelor's Degree

Herramientas

Microsoft Office (Word, Excel, PowerPoint, Teams, Outlook, SharePoint)

Smartsheet

Descripción del empleo

PCI Pharma Services is seeking an organized administrator to support R&D documentation and data management in a fast-paced pharmaceutical development environment. The role focuses on document control, data reporting, and change control coordination within cGMP guidelines.

The candidate will handle templates, forms, and records, collaborate with multiple departments, and support onboarding and training documentation as part of ongoing process improvements.