(Senior) Consultant Qualification & Validation - Freelancer

Darum lohnt es sich

About the role As a (Senior) Consultant Qualification & Validation, you will play a key role in ensuring compliance and quality within the life sciences industry.

You will independently manage and execute qualification and validation activities for equipment, utilities, facilities, computerised systems, and processes, ensuring adherence to GxP standards and global regulatory requirements (FDA, EMA, WHO, ISPE GAMP 5).

Acting as a primary contact for clients, you will lead projects from planning to completion, provide strategic guidance, and build strong client relationships. This role requires working on-site at client locations across Germany, providing hands-on support and ensuring successful project delivery.

Key Responsibilities Independently lead validation and qualification activities for equipment, utilities, facilities, computerised systems and processes Ensure high-quality, compliant deliverables according to GxP standards and regulatory requirements (e.g.

FDA, EMA, WHO, ISPE GAMP 5) Prepare, review and approve validation documentation, including Validation Plans, Risk Assessments, URS, IQ/OQ/PQ protocols and Validation Reports Troubleshoot validation-related issues, identify root causes and propose pragmatic, compliant solutions Prepare, execute and document processes validation for Manufacturing, Labelling and Packaging Prepare, execute and document cleaning validation for Production line and equipment like cleaning, mobile & multipurpose Manage project timelines, r