Computer System Validation Consultant

Following a new opportunity in partnership with Takeda, one of the top 10 Pharmaceutical Companies in the World, we are currently looking for a CSV Consultant based or willing to relocate in Bratislava, Slovakia.

​Your journey will start with PQE Group for an initial paid 9-month period, in order to acquire the technical skills that the role requires.

But after successfully completing this period and showcasing your skills, Takeda will be pleased to extend a job offer, welcoming you as a permanent, internal member of their team at the Innovation Capability Center (ICC) in Bratislava, Slovakia.​

You will be responsible for

• Develop and execute a strategic CSV plan that aligns with the company's overall compliance and quality objectives. This includes defining validation strategies, risk assessment methodologies, and validation lifecycle models.
• Oversee the development and review of comprehensive validation documentation, including Validation Plans, URS, FS, IQ/OQ/PQ protocols, validation reports, and traceability matrices.
• Conduct risk assessments for computer systems, identify potential vulnerabilities, and implement risk mitigation strategies.
• Establish and maintain a robust change control process to manage system changes and updates in compliance with validation requirements.
• Provide guidance on validation testing methodologies, including test design, execution, and documentation. Ensure that testing meets regulatory expectations.