Quality Assurance Specialist Aseptic Production (temporary, 100%, 1 year)

Overview

Congenius provides tailored expertise and leadership to global firms, established SME`s and aspiring start-ups in the medical device, IVD and pharmaceutical industry. If you enjoy working with a diverse range of people across a broad range of projects and are passionate about making a positive contribution to the MedTech industry, then joining our dynamic team could be your next rewarding career step.

Responsibilities

• Ensure compliance with GMP requirements in aseptic production environments (Grade A/B cleanrooms) and microbiological laboratories
• Conduct regular Gemba Walks on the production floor and laboratories to monitor quality standards
• Review and support deviation reports, investigations, and CAPAs
• Act as QA representative in cross-functional project teams
• Provide quality input including risk assessments and QA opinions
• Support and deliver training sessions (classroom and on-the-jo...