CSV Compliance Specialist - German Speaker - Freelance - Basel/Hybrid

Robson Bale are looking for a German Speaking CSV Compliance Specialist to come on board for an initial 6 month contract in Basel.

6 months, market rate.

Hybrid

Candidates MUST Speak German for this role

Tasks and Responsibilities

• Create and deliver CSV documentation, including Validation Plans, Requirements Specifications, Test Protocols, and Summary Reports.
• Ensure security and compliance solutions and projects comply with QA and CSV procedures and regulatory standards.
• Collaborate with project teams to gather information and ensure accurate documentation.
• Review and update CSV documents to reflect system and process changes.
• Execute validation tests as necessary.
• Train and support project teams on CSV documentation requirements.
• Stay updated with CSV best practices and regulatory requirements.
• Enable projects to comply with CSV requirements when using Agile project management methodology.
• Coach colleagues on validation and qualification activities, supporting training for teams new to CSV compliance in projects.

Requirements

• Bachelor's degree in computer science, IT, or a related field.
• Minimum of 3 years of experience in delivering CSV compliance testing and documentation.
• In-depth knowledge of Waterfall and Agile project management methodologies.
• Strong experience in running CSV compliance activities for projects managed in Agile.
• Comprehensive understanding of GMP regulations and guidelines applied in pharmaceuticals.
• Exceptional documentation skills with a focus on detail and accuracy.
• Ability to work independently and manage concurrent tasks.
• Effective communication and team collaboration skills.