R&D Documentation & Data Coordinator

pciservices; León; Presencial; EUR 32.000 - 42.000; Jornada completa

Descripción de la vacante

PCI Pharma Services is seeking an organized Documentation Specialist to manage R&D documentation, data integrity, and cGMP compliance. You will generate reports, maintain controlled documents, and support change controls within a multidisciplinary pharmaceutical development environment.

The role requires strong MS Office and Smartsheet skills, plus the ability to coordinate with Quality Assurance, Quality Control, and Project Management teams. Experience with GMP environments is preferred.

Formación

• Essential knowledge of cGMP documentation practices and data integrity requirements.
• Experience with documentation management principles and pharmaceutical development processes.
• Proficient with MS Office applications and Smartsheet/SharePoint.
• Ability to manage multiple administrative tasks with accuracy and attention to detail.

Responsabilidades

• Document Management and Control: organize, scan, archive, and maintain R&D documentation.
• Data Management and Reporting: update databases, generate reports and trend analyses.
• Change Control Support: coordinate basic change controls and updates with project teams.
• Protocol and Report Preparation: create protocols and reports using approved templates.
• Training Administration: monitor training compliance and maintain records.
• Procurement and Shipment Coordination: handle purchase orders and R&D shipments.
• Continuous Improvement: identify opportunities to improve documentation workflows and compliance.
• Compliance: adhere to cGMP and internal policies.

Conocimientos

Document management

Data integrity

cGMP knowledge

Multitasking

Communication

Educación

Associate Degree

Bachelor's Degree

Vocational Training

Herramientas

Smartsheet

Microsoft Office

SharePoint

Descripción del empleo

PCI Pharma Services is seeking an organized Documentation Specialist to manage R&D documentation, data integrity, and cGMP compliance. You will generate reports, maintain controlled documents, and support change controls within a multidisciplinary pharmaceutical development environment.

The role requires strong MS Office and Smartsheet skills, plus the ability to coordinate with Quality Assurance, Quality Control, and Project Management teams. Experience with GMP environments is preferred.