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Computer System Validation Expert (all gender) at ALTEN - ApplyBlast

Computer System Validation Expert (all gender)

ALTEN

2 months ago

3.4 on Glassdoor

Mannheim, Baden-Württemberg, Germany

Onsite

Full Time

Senior

0 applicants

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About this role

The role involves planning, executing, and documenting validation activities for computer-based systems in the pharmaceutical industry, ensuring compliance with GAMP 5, FDA 21 CFR Part 11, GxP, and GMP throughout the system lifecycle. The expert will collaborate with IT, QA, and functional departments, develop validation strategies from risk analyses, and support audits and inspections.

Responsibilities

Plan and execute validation activities per GAMP 5 and FDA 21 CFR Part 11
Collaborate with IT, QA and business units to ensure regulatory compliance
Lead risk analyses and support audits and inspections

Skills

Qualifications

Bachelor in Computer ScienceBachelor in EngineeringBachelor in Pharmacy

About ALTEN

alten.com

Headquarters

Boulogne-Billancourt, Île-De-France, France

Company Size

10001+ employees

Founded

1988

View Profile

Alten is a global engineering and technology consulting firm headquartered in France that provides R&D, engineering and IT services to industrial and technology clients. It supports product development, systems engineering, embedded and software development, testing and digital transformation across sectors such as aerospace, automotive, rail, telecoms, energy, defense and life sciences. Acting as an R&D and engineering outsourcing partner, Alten deploys thousands of consultants across Europe, the Americas and Asia to help clients accelerate innovation and bring complex products and systems to market. The company is known for its technical expertise, long-term client relationships and ability to combine local delivery with global scale.