R&D Documentation & Compliance Specialist

PCI TRGR Penn Pharmaceutical Services Ltd; León; On-site; EUR 25,000 - 38,000; Full time

Job summary

PCI Pharma Services is seeking an organized Documentation & Compliance Administrator in Spain to maintain R&D documentation, generate controlled documents, and support change controls and reporting. You will work with cross-functional teams to ensure traceability, accuracy, and regulatory compliance.

The role requires familiarity with cGMP, strong MS Office and Smartsheet skills, and the ability to handle multiple tasks with precision in a fast-paced environment.

Qualifications

• Essential associate degree or higher in a relevant field.
• Experience with Microsoft Office applications (Word, Excel, PowerPoint, Teams, Outlook, SharePoint) and Smartsheet.
• Familiarity with cGMP documentation practices and document control systems is highly desirable.
• Creative with the ability to work with minimal supervision and balance with independent thinking.
• Honesty, integrity, respect and courtesy with all colleagues.

Responsibilities

• Document Management and Control – Organize, scan, archive, and maintain R&D department documentation with traceability and version control.
• Documentation Issuance – Generate forms, templates, labels, logbooks, and documentation for trials and development activities.
• Data Management and Reporting – Maintain departmental databases and prepare process charts and trend analyses.
• Change Control Support – Coordinate basic change controls and update documentation with project teams.
• Protocol and Report Preparation – Prepare simple protocols and reports using approved templates.
• Production Data Collection and Analysis – Collect data from manufacturing equipment and generate process charts.
• Training Administration – Monitor training compliance and maintain training records.
• Personnel Administration – Assist onboarding/offboarding and maintain records.
• Procurement and Shipment Coordination – Manage purchase orders and organize R&D shipments.
• Continuous Improvement – Identify opportunities to improve documentation workflows and compliance.
• Compliance – Adhere to company policies and GMP requirements.

Skills

cGMP documentation practices

Document control systems

Microsoft Office

Smartsheet

Organizational skills

Communication skills

Interpersonal skills

Education

Associate/Bachelor level degree

Tools

Smartsheet

Excel

Word

PowerPoint

Teams

Outlook

SharePoint

Job description

PCI Pharma Services is seeking an organized Documentation & Compliance Administrator in Spain to maintain R&D documentation, generate controlled documents, and support change controls and reporting. You will work with cross-functional teams to ensure traceability, accuracy, and regulatory compliance.

The role requires familiarity with cGMP, strong MS Office and Smartsheet skills, and the ability to handle multiple tasks with precision in a fast-paced environment.