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Job Opportunity: Quality Assurance Associate
Location: Bern, Switzerland
Start Date: 01 July 2025
End Date: 30 June 2026
Full-time - 12-month contract, possible extension
Are you ready to contribute to life-saving therapies while developing your expertise in aseptic manufacturing and GMP compliance? We are looking for a dedicated and detail-oriented Quality Assurance Associate to join our team.
Your Key Responsibilities
As part of our Quality Assurance team, you will:
* Provide support and guidance in the areas of aseptic manufacturing and microbiological laboratories (no hands-on lab/manufacturing work).
* Ensure GMP compliance in production by performing regular checks and process reviews.
* Actively contribute to projects including:
o Commissioning a new aseptic filling line
o Implementation of regulatory updates (e.g., EU GMP Annex 1)
* Review and document production processes, workflows, and quality standards.
* Support and (re)qualify production personnel through training initiatives.
* Provide on-site quality support during manufacturing, with a focus on compliance and risk assessment.
* Manage and investigate complex deviations in aseptic filling and visual inspection:
o Initial evaluation and risk classification
o Support definition of investigation strategies and technical assessments
o Collaborate on CAPA development to prevent recurrence
o Review deviation reports (German & English) for compliance and risk accuracy
* Prepare and present deviations during internal and external audits.
* Review SOPs and other quality documentation.
Your Profile
* Degree in a life sciences field (BSc, MSc or PhD) or equivalent qualification
* Minimum 2 years of experience in a GMP-regulated environment, ideally in the pharmaceutical industry
* Strong analytical thinking with the ability to present complex topics clearly and logically
* Critical thinking and keen eye for structured, high-quality documentation
* Team player with strong communication and influencing skills across all levels
* Flexible, proactive, and able to manage multiple priorities
* Fluent in German (native level) and business fluent in English, both written and spoken
* Comfortable working in a mixed office/cleanroom setting (approx. 80% office, 20% cleanroom - Grade C/D/E)
What We Offer
* A unique opportunity to work in a global biopharmaceutical environment with a clear mission to save lives
* Dynamic and supportive team culture
* Professional development in quality assurance and aseptic manufacturing
* Exposure to cutting-edge facilities and technologies
Apply now to become a vital part of our quality team and contribute to the safe production of life-changing therapies.
Seniority level
* Seniority level
Not Applicable
Employment type
* Employment type
Full-time
Job function
* Job function
Quality Assurance
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