QA Validation Engineer - Medical Devices

at  Michael Page Switzerland

ABOUT OUR CLIENT

Our client is a rapidly growing medical device company at the forefront of innovation in the healthcare industry. With a strong commitment to research and development, our client is expanding its operations and continuing to build on its success, offering exciting opportunities for professionals to join their dynamic and forward-thinking team.

JOB DESCRIPTION

As a QA Validation Engineer, you will play a critical role in ensuring the compliance and validation of the facilities, utilities, equipment, and processes according to regulatory requirements. Your expertise will be essential in reviewing and approving validation documentation, developing validation strategies, and maintaining the validated state of our operations.

• Validation and Qualification Maintenance:
• Contribute to maintaining the validated state of facilities, utilities, equipment, and processes.
• Ensure all activities comply with relevant regulatory requirements and internal quality standards.
• Document Review and Approval:
• Review and approve validation and qualification documents, including validation plans, protocols, final reports, risk assessments, and user requirement specifications.
• Provide technical and quality expertise during the review process to ensure compliance and accuracy.
• Validation Strategy Development:
• Participate in the development of qualification and validation strategies for new and existing projects.
• Collaborate with cross-functional teams to align validation activities with overall project goals and regulatory expectations.
• Equipment and Process Validation:
• Review and approve protocols and reports related to the initial qualification, periodic requalification, and revalidation of equipment, clean rooms, laboratories, and utilities.
• Oversee validation activities for sterilization, manufacturing, filling, cleaning, and depyrogenation processes.
• Quality Metrics and Continuous Improvement:
• Maintain and update quality indicators related to qualification and validation processes.
• Review and approve deviations identified during protocol execution and ensure proper resolution.
• Risk Analysis:
• Participate in risk analyses for equipment and processes, ensuring that all potential risks are identified, assessed, and mitigated appropriately.

• Validation and Qualification Maintenance:
• Contribute to maintaining the validated state of facilities, utilities, equipment, and processes.
• Ensure all activities comply with relevant regulatory requirements and internal quality standards.
• Document Review and Approval:
• Review and approve validation and qualification documents, including validation plans, protocols, final reports, risk assessments, and user requirement specifications.
• Provide technical and quality expertise during the review process to ensure compliance and accuracy.
• Validation Strategy Development:
• Participate in the development of qualification and validation strategies for new and existing projects.
• Collaborate with cross-functional teams to align validation activities with overall project goals and regulatory expectations.
• Equipment and Process Validation:
• Review and approve protocols and reports related to the initial qualification, periodic requalification, and revalidation of equipment, clean rooms, laboratories, and utilities.
• Oversee validation activities for sterilization, manufacturing, filling, cleaning, and depyrogenation processes.
• Quality Metrics and Continuous Improvement:
• Maintain and update quality indicators related to qualification and validation processes.
• Review and approve deviations identified during protocol execution and ensure proper resolution.
• Risk Analysis:
• Participate in risk analyses for equipment and processes, ensuring that all potential risks are identified, assessed, and mitigated appropriately