Senior Systems Validation Expert

beBeeSystem; Madrid; Híbrido; EUR 50.000 - 70.000; Jornada completa

Descripción de la vacante

A leading consulting firm in Madrid is seeking a Senior Consultant with expertise in computerized systems validation. You will oversee validation projects, ensuring compliance with industry regulations and enhancing efficiency. Required qualifications include a Bachelor's degree in Chemistry or Engineering, solid experience in the pharmaceutical sector, and fluency in both Spanish and English. The position offers a competitive compensation package and a flexible hybrid work model.

Servicios

Competitive compensation

Flexible work hours

Global exposure

Opportunities for growth

Formación

• Solid experience in the pharmaceutical industry required.
• Experience in managing multiple consulting projects necessary.
• Valid driver's license and willingness to travel by car.

Responsabilidades

• Oversee projects involving validation of computerized systems.
• Ensure compliance with EU GMP, FDA 21 CFR, GAMP 5.
• Assess system compliance with global standards.

Conocimientos

Computerized systems validation

GxP compliance

Multitasking

Fluency in Spanish

Fluency in English

Educación

Bachelor's degree in Chemistry or Engineering

Herramientas

ERPs

eDMS

eQMS

LIMS

SCADAs

EBRs

Pharmacovigilance systems

Descripción del empleo

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

• A 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.

Benefits

• 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.

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.