Pharma CSV Specialist: Lead Validation & Data Integrity

Fortil Switzerland SA; Brussel Hoofdstad; Sur place; EUR 60 000 - 80 000; Plein temps

Avantages offerts par ce poste

High-value project opportunities

Dynamic work environment

Fast-track skill development

Résumé du poste

Fortil Switzerland SA is seeking a CSV Specialist to ensure compliance of computerized systems within the pharmaceutical industry. In this role, you will lead Computer System Validation (CSV) activities, manage validation documentation, and collaborate cross-functionally to uphold regulatory standards.

The ideal candidate has a degree in Computer Science or a related field, along with 3 to 7 years of experience in CSV. You will be working in a challenging environment that promotes fast-track skill development and career growth.

Qualifications

• 3 to 7 years of experience in Computer System Validation (CSV) within the pharmaceutical or biotech industry.
• Strong knowledge of GAMP5, GMP, FDA 21 CFR Part 11, ICH, EU guidelines.
• Professional level of English (written and spoken).

Responsabilités

• Execute and lead Computer System Validation (CSV) activities in compliance with GAMP5, GMP, and 21 CFR Part 11.
• Prepare and manage validation documentation: validation plans, risk assessments, test strategies, and protocols.
• Collaborate with cross-functional teams to ensure compliance with regulations.

Connaissances

Computer System Validation (CSV)

GMP knowledge

Regulatory compliance

Cross-functional teamwork

Attention to detail

Formation

Bachelor’s or Master’s degree in Computer Science, Engineering, or related scientific field

Outils

LIMS

CDS

BMS

SAP

JDE

Description du poste

Fortil Switzerland SA is seeking a CSV Specialist to ensure compliance of computerized systems within the pharmaceutical industry. In this role, you will lead Computer System Validation (CSV) activities, manage validation documentation, and collaborate cross-functionally to uphold regulatory standards.

The ideal candidate has a degree in Computer Science or a related field, along with 3 to 7 years of experience in CSV. You will be working in a challenging environment that promotes fast-track skill development and career growth.