QA Manager

Summary

Join Cerba Research as a QA CSV Manager and contribute to improving global health. In this integral role within the QA team, you will provide GCP advice to ensure quality, data integrity, and safety of services. You will oversee and approve computer system validation activities, ensuring compliance with regulatory standards. Responsibilities include reviewing validation documentation, driving project completion, and participating in audits. You will utilize modern QMS tools and maintain high quality standards. This is a dynamic, fast-paced environment offering opportunities for growth and skill development.

Requirements

• Bachelor’s degree in Life Sciences, Engineering, Computer Science, or equivalent technical experience
• 1 year of experience supporting CSV / IT projects in a Quality Assurance or IT Quality position
• 3 years of experience in Quality Assurance and/or a similar role in a GxP environment
• Excellent communication skills
• Strong troubleshooting skills
• Experience in use of modern Quality Management Systems (QMS) (such as Veeva, MasterControl, Trackwise)

Responsibilities

• Provide advice on all aspects of GCP to support the quality, data integrity and safety of services provided by Cerba Research
• Contribute to the Quality oversight of reviewing and approving computer system validation activities ensuring compliance with FDA, EMA, GAMP 5, and internal policies
• Independently review lifecycle validation documentation and system changes
• Assist in driving validation project completion, incorporating quality by design principles, supporting computerized systems investigations, and participating in internal and external audits as a quality specialist
• Ensure a consistent approach to qualification, change, and deviation management across systems
• Utilize modern QMS tools like Veeva, MasterControl, and Trackwise to maintain high standards of quality

Benefits

• Grow your career in a dynamic, fast paced environment, where you can develop new skills and work on diverse projects
• Plenty of room for initiatives