Quality Manager, CSV for Cloud Systems (GAMP5)

B. Braun Group; Barcelona; Hybrid; EUR 45,000 - 55,000; Full time

Benefits offered by this job

Hybrid working model

Meal allowance

Private health insurance

Company-funded training

Annual leave 23 days

Live and accident insurance

Job summary

B. Braun Medical, S.A. in Barcelona is seeking a Quality Manager to lead computerized system validation activities within Group Digital Department (GDD). The role focuses on developing robust CV processes, risk-based validation, and ensuring compliance with GAMP 5 and internal standards.

The ideal candidate has a degree in a related field, CSV experience, and strong English communication. The position offers hybrid work and a comprehensive benefits package in a dynamic tech hub.

Qualifications

• Experience in Computerized System Validation (CSV) and quality procedures.
• Knowledge of GAMP 5 principles and risk-based qualification approaches.
• Exposure to cloud-based services and software development processes.
• Strong written and verbal English communication skills.

Responsibilities

• Develop, maintain, and improve qualification and validation processes for computerized systems per GAMP 5 and internal requirements.
• Support risk-based qualification and validation activities for systems including cloud services and web apps.
• Create, review, and maintain qualification and validation documentation (plans, RISKS, requirements, test docs, traces, reports).
• Ensure CV/validation requirements are integrated into system development, implementation, operation and change management.

Skills

CSV experience

GAMP 5

Risk-based validation

Cloud services knowledge

Software quality assurance

English communication

Attention to detail

Delivery-focused

Continuous learner

Education

Degree in Computer Science or Engineering or IT or Quality Management

Job description

B. Braun Medical, S.A. in Barcelona is seeking a Quality Manager to lead computerized system validation activities within Group Digital Department (GDD). The role focuses on developing robust CV processes, risk-based validation, and ensuring compliance with GAMP 5 and internal standards.

The ideal candidate has a degree in a related field, CSV experience, and strong English communication. The position offers hybrid work and a comprehensive benefits package in a dynamic tech hub.