Validating Complex Systems for Pharmaceutical Industries

Overview

Senior System Validation Consultant

Deliver high-quality projects in compliance and validation, driving business outcomes across the industry.

Ensure adherence to stringent regulations, including EU GMP Annex 11, FDA 21 CFR Part 11, and Data Integrity guidelines.

Work with diverse systems, including ERPs, eDMS, eQMS, LIMS, laboratory systems, SCADAs, EBRs, pharmacovigilance, and maintenance systems.

Audit software suppliers to verify regulatory compliance.

Provide expert assessments of compliance risks and propose actionable solutions.

Contribute to projects across Spain, Europe, and China, bringing expertise to clients in various regulatory environments. Represent company values while working on-site with clients, ensuring seamless collaboration and delivering quality results.

Responsibilities

Deliver high-quality projects in compliance and validation, driving business outcomes across the industry.

Audit software suppliers to verify regulatory compliance.

Provide expert assessments of compliance risks and propose actionable solutions.

Requirements

Bachelor's degree in Chemistry or Engineering.

Solid experience in the pharmaceutical industry, GxP compliance, and computerized systems validation.

Strong multitasking skills and experience in managing multiple consulting projects to meet client needs.

Fluency in Spanish and English, with excellent communication skills.

This is a chance to make a significant impact while growing your career in CSV consulting. You will work in a dynamic environment where your contributions are valued, and your ideas can shape the future of the company.

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