Profesional de Apoyo Técnico
Core
Provide technical and regulatory support to the Technical Directorate by managing stability studies, technical documentation, regulatory requirements, and scientific data analysis to ensure compliance with quality standards and applicable regulations.
Role type
Technical Support Specialist (Pharmaceutical Quality)
Builds
Stability study reports, regulatory compliance documentation, OOS/OOT investigation reports
Domain
Pharmaceutical industry / Quality Control / Regulatory Affairs
Required skills
Pharmaceutical legislation knowledge, Laboratory Good Practices (BPL), Out-of-Specification (OOS) and Out-of-Trend (OOT) investigation, Analytical method validation, Root cause analysis, Corrective and Preventive Actions (CAPA), Project management support, Quality policy compliance
Preferred skills
Experience in stability studies, Analytical validation, Regulatory requirement updates
Technologies
Stability study software, Laboratory Information Management Systems (LIMS), Regulatory databases
Responsibilities
Coordinate and follow up on stability studies (accelerated, long-term, ongoing, and in-use), Review analytical reports and validation protocols, Evaluate and follow up on OOS/OOT results, Manage updates of regulatory and normative requirements, Respond to technical requests from clients and regulatory entities, Support technical areas under the Technical Directorate, Maintain technical documentation and records, Support training activities on technical and regulatory aspects, Participate in root cause analysis and continuous improvement projects, Support laboratory project management and decision-making, Ensure compliance with quality, safety, and environmental policies