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Senior Systems Validation Expert
beBeeSystemMadrid, Comunidad de Madrid, EspañaHace 4 días
Descripción del trabajoA Bachelor\'s degree in Chemistry or Engineering is required. Solid experience in the pharmaceutical industry, GxP compliance, and computerized systems validation is essential. Strong multitasking skills and experience in managing multiple consulting projects to meet client needs are necessary. Fluency in Spanish and English, with excellent communication skills, is required. A valid driver\'s license and willingness to travel by car are also required. A competitive compensation and benefits package is offered. A flexible work hours and hybrid work model provide a great work-life balance. Global exposure and opportunities for growth make this role an exciting opportunity.
Overview
We are seeking a senior consultant with expertise in computer system validation to lead impactful projects in compliance and validation, contributing to innovative areas.
Responsibilities
- This position involves overseeing projects involving the validation of computerized systems across the project lifecycle, including preparation of critical documentation.
- You will ensure strict adherence to industry regulations, such as EU GMP Annex 11, FDA 21 CFR Part 11, GAMP 5, and Data Integrity guidelines.
- Working with widely used systems, including ERPs, eDMS, eQMS, LIMS, laboratory systems, SCADAs, EBRs, pharmacovigilance, and maintenance systems.
- Assessing system compliance with global standards to ensure efficiency and regulatory readiness.
Requirements
Benefits
Rephine has been improving manufacturing quality processes for leading Life Sciences companies for over 20 years. We are looking for passionate professionals eager to grow with us.
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Senior Expert • Madrid, Comunidad de Madrid, España
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