R&D Administrator

About the role

PCI Pharma Services is looking for an R&D Administrator in Leon. The role supports the R&D department's documentation, data and administrative needs, working with R&D management, scientists, technicians and project teams, and with Quality Assurance, Quality Control, Supply Chain, Operations, Human Resources, Purchasing and Project Management.

Key responsibilities

• Document management: organize, scan, archive and maintain R&D documentation, ensuring traceability, version control, template management and compliance with internal procedures and GMP requirements.
• Issue forms, templates, labels and logbooks for R&D trials, equipment runs, engineering batches, manufacturability and pre-stability studies.
• Maintain departmental databases and tracking tools in Smartsheet, Excel and other systems, and prepare process charts, reports and trend analyses.
• Support basic document-related change controls and prepare simple protocols, reports and controlled documents.
• Collect primary data from manufacturing equipment according to cGMP requirements and generate process monitoring charts.
• Monitor training compliance, support training records, and support onboarding and offboarding of R&D personnel.
• Manage purchasing requests, purchase orders, receipt of materials and samples, and organize R&D shipments.
• Identify improvements to documentation workflows and administrative processes, and comply with company policies, quality standards, safety requirements and cGMP regulations.

Required profile

• Associate degree, vocational training or bachelor's degree.
• Knowledge of cGMP, documentation management, data integrity and pharmaceutical development processes.
• Ability to handle multiple administrative tasks accurately and independently, with strong organization and communication skills.
• Familiarity with cGMP documentation practices and document control systems is highly desirable.

Required skills

• Microsoft Office (Word, Excel, PowerPoint, Teams, Outlook, SharePoint)
• Database management tools such as Smartsheet