Quality and Validation Consultant (m/f)

Description

• Serve as technical expert for the validation process and responsibilities to ensure compliance
• Suggest and sometimes implement innovation and continuous improvement within the validation process
• Implement initiatives in the validation process that will deliver customer value at lowest cost
• Update/compile process validation documents (Engineering Studies, IQ, OQ, PQ) and execute/follow these validations
• Ensure all validation activities and documents are authorized and appropriate compliance approval is gained
• Continuous learning/managing risks; ensure compliance through assisting in audits
• Update/compile URS (User Requirement Specifications) for the machine and modules of it

• Profound knowledge of bespoke validation as well as process knowledge and documentation
• In-depth knowledge of European regulations associated with the medical device industry
• High understanding of GMP, compliance, validation practices, including the system development life cycle and regulatory expectations
• Working experience of validation computer systems for use in a FDA regulated environment
• Qualification in an appropriate discipline (e.g. Engineering, Information Systems or Life Science with additional IT qualification) with a broad technical/educational skills base
• Experience of working in a regulated environment, including carrying out validation and/or testing activities
• Fluency in English and German