Quality Assurance Specialist Aseptic Production; temporary

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 Med Tech industry, then joining our dynamic team could be your next rewarding career step.

• Ensure compliance with GMP requirements in aseptic production environments (Grade A/B clean rooms) 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-job) for production staff
• Collaborate closely with manufacturing and other stakeholders to ensure continuous improvement
• Support batch release-related QA activities (as applicable)
• Maintain and improve quality documentation and procedures

• Minimum bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, or related field
• Initial experience in Quality Assurance or aseptic manufacturing
• Solid understanding of GMP requirements, ideally in sterile/aseptic environments
• Experience working in cleanroom environments (Grade A/B preferred)
• Strong communication skills and ability to work cross-functionally
• Structured, detail-oriented, and quality-driven mindset
• Ability to work independently and take ownership of tasks
• Ideally first-hand experience in QA project work and risk management
• Willingness to work on-site in Bern with flexible working hours (occasionally early or late shifts)
• Fluent in English and native German is a must
• You will work in Bern for an ambitious, dynamic company
• You benefit from a versatile field of activity
• You work in a company with a flat hierarchy, short decision-making processes
• You can expect a pleasant working atmosphere, an uncomplicated and collegial cooperation
• You benefit from modern and attractive working conditions
• An attractive salary and very good social benefits round off the offer
• The contract is limited to 1 year with a high likelihood of an extension