CSV Specialist (M/F) - Pharmaceutical Industry

Fortil is an international engineering and technology consulting group, built on an independent model and bringing together over 2,500 employees across 14 countries. Fortil fosters an entrepreneurial mindset and empowers individuals to unlock their full potential.

YOUR ROLE

As part of projects in the pharmaceutical industry, you will act as a CSV Specialist, ensuring that computerized systems comply with regulatory requirements.

Your main responsibilities will include:

• 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, impact assessments, URS, risk assessments, test strategies, protocols, SOPs, and periodic reviews.

• Validate computerized systems and equipment (laboratory, manufacturing, IT systems).

• Ensure data in...