Pharma IT Applications (R&D; & Clinical)

Experience supporting and improving IT applications used in the pharmaceutical industry, both in research laboratories (R&D; – Research & Development) and in clinical processes (such as clinical trials involving patients).

These systems operate under strict regulatory requirements (GxP/GAMP5), meaning that all activities (usage, changes, data handling) must be controlled, documented, and auditable.

? Laboratory Systems

Hands-on experience with systems commonly used in laboratories:

- LIMS (Laboratory Information Management System): software used to manage laboratory samples, test results, and associated data
- ELN (Electronic Lab Notebook): a digital notebook where researchers document experiments and findings
- CDS (Chromatography Data System): software used to collect and analyze data from laboratory instruments (e.g., chromatography equipment)

Typical responsibilities include:
- User support
- Incident resolution
- System maintenance and enhancements

? Clinical & Regulatory Processes Understanding of processes related to clinical studies and regulatory compliance:

- Clinical workflows: how clinical trials are managed (patient data, study tracking, data collection)
- Pharmacovigilance: systems used to monitor the safety of drugs,



including tracking adverse effects
- Regulatory tools: applications used to ensure compliance with health authority requirements

The main goal is to ensure that all processes comply with strict pharmaceutical regulations. ? GxP Compliance & Validation

Experience working under regulated quality standards:

- GxP (Good “x” Practices): a set of regulations designed to ensure product quality, safety, and data integrity (e.g., GCP, GMP, GLP)
- GAMP5: a framework for validating computerized systems in regulated environments

This includes:
- System validation (ensuring systems work as intended and meet requirements)
- Change control (managing and documenting system changes)
- Quality assurance (ensuring compliance and audit readiness)

? Application Support & Continuous Improvement Providing both functional and technical support for critical applications:

- Troubleshooting and incident resolution
- Process and system optimization
- Continuous improvement of tools and workflows

All within regulated environments where systems are business-critical and must meet strict compliance standards.

Language

Spanish | English Elementary

📌 Pharma IT Applications (R&D Clinical) (España)
🏢 Novacomp
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