Job Overview

We are looking for 2 IT Application Support Specialists (R&D; & Clinical) to join a key systems migration and continuous support project for two major European clients in the Laboratory and Healthcare sectors.

The adecuado candidate has hands-on experience in supporting and optimizing pharmaceutical IT systems, as well as a solid foundation in GxP regulations and GAMP5 guidelines.

Key Responsibilities

- Provide functional and technical support for critical R&D;, laboratory, and clinical applications.
- Lead troubleshooting, incident resolution, and continuous improvement of critical systems.
- Actively support system migration activities, ensuring uninterrupted operations and data integrity.
- Manage and maintain core laboratory systems: LIMS, ELN, and CDS (Chromatography Data Systems).
- Ensure full regulatory compliance across clinical workflows, pharmacovigilance tools, and regulatory systems.




- Execute system validation, change control management, and quality assurance under GxP (GCP, GMP, GLP) and GAMP5 frameworks.

Key Requirements

- Language Skills: Spanish and Business English
- Schedule Availability: Must be able to work early shifts to ensure direct overlap with European working hours (CET).
- Proven experience supporting IT applications within the Pharmaceutical, Biotech, or Healthcare industries.
- Hands-on experience with at least one core laboratory application: LIMS, ELN, or CDS.
- Solid understanding of clinical trial workflows, regulatory compliance, and pharmacovigilance processes.
- Strong background working in GxP-regulated environments and implementing GAMP5 computerized system validation.

stems

📌 Pharma IT Application Support Specialist (México)
🏢 Orbitware
📍 México