Overview
Quality Assurance Specialist Aseptic Production (temporary, 100%, 1 year) Jobs in Berne, Switzerland at Congenius AG
Title: Quality Assurance Specialist Aseptic Production (temporary, 100%, 1 year)
Company: Congenius AG
Location: Berne, Switzerland
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.
Your 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-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
Your Skills and Experience
- 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 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
Your Benefits
- 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
