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Quality assurance associate

Bern
Swisslinx
EUR 30’000 - EUR 80’000 pro Jahr
Inserat online seit: 15 Juni
Beschreibung

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Job Description


Job Description

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

Entry level


Employment type

* Employment type

Contract


Job function

* Job function

Quality Assurance
* Industries

Staffing and Recruiting

Referrals increase your chances of interviewing at Swisslinx by 2x

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