Quality Assurance Associate – 6489 ADA

Our client is a specialist biotherapeutics manufacturer with over a century of experience treating various diseases worldwide. They are committed to patients with coagulation disorders, immunological diseases, enzyme deficiency diseases, and other rare diseases.

We are seeking a highly skilled Quality Assurance Associate for a 12-month contract position at our client's headquarters in Bern. In this role, you will be part of a team responsible for ensuring GMP-compliant processing of deviations, complaints, and complex quality issues, supporting the high-quality standards of products for customers. Fluency in both English & German is mandatory

Main Responsibilities:

·      Support and consulting in the area of ​​aseptic manufacturing and microbiological laboratories (no performance of activities within manufacturing or the laboratory)

·      Review and ensure compliance with GMP requirements in production

·      Control, review, and documentation of work steps, review of processes in aseptic production.

·      Participation in the training and (re)qualification of aseptic production employees

·      Support for deviations in the area of ​​aseptic filling:

o  Conducting initial assessments

o  Supporting the definition of the investigation strategy, including the evaluation of technical assessments within the scope of the investigation.

o  Supporting the operations group in the deviation investigation, including the definition of appropriate corrective and preventive actions (CAPAs) to prevent the recurrence of a similar deviation.

o  Reviewing the investigation reports in German and English and assessing them for compliance and risk assessment.

·      Participation in the preparation of deviations within the scope of internal and external inspections.

·      Support in reviewing specification documents

Qualifications & Experience:

  • Relevant working/residency permit or Swiss/EU-Citizenship required
  • Educational Background: Degree in a scientific field (preferably Pharmacy, Chemistry, or Biology).
  • Experience: Ideally, experience within a pharmaceutical company and GMP environment.
  • 1-2 years of experience in Quality Assurance/Quality Control
  • 1-2 years of experience with QMS
  • Strong enthusiasm, analytical thinking, and effective communication skills.
  • Precise and reliable work approach with the ability to prioritize effectively.
  • Flexibility and ability to work independently as well as in a team, maintaining composure in fast-paced environments.
  • Languages: Proficiency in German and English, both spoken and written.
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