Senior Quality Assurance Specialist– 6541 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 Senior Quality Assurance Specialist 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 advice in the area of ​​aseptic production and microbiological laboratories (no performance of activities within production or the laboratory)

• Checking and ensuring compliance with GMP requirements in production

• Taking on and participating in projects in the area of ​​aseptic production (in particular involvement in the commissioning of a new filling line, implementation of additional regulatory requirements (Annex 1))

• Monitoring, checking and documenting work steps, reviewing processes in aseptic production.

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

• Supporting production in the event of problems throughout the entire production period with regard to compliance and risk assessment

• Supporting complex deviations in the area of ​​aseptic filling and visual inspection.

o Carrying out initial assessments

o Supporting function in defining the investigation strategy, including evaluation of technical assessments as part of the investigation.

o Supporting the operations group in investigating deviations, including defining suitable corrective and preventive actions (CAPAs) to prevent a similar deviation from occurring again.

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

• Preparing and presenting deviations as part of internal and external inspections.

• 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).

• A scientific degree (Bachelor's, Master's or PhD) or comparable qualification.

• At least 2 years of experience in GMP, ideally from the pharmaceutical industry.

• An analytical mindset and the ability to quickly grasp complex relationships and present them in an easily understandable, logically structured manner.

• Good understanding of the logical structure of texts and reports and the ability to question them

• Team-oriented thinking, strong communication skills, assertiveness and the ability to approach people at all levels of the hierarchy.

• Ability to quickly change focus between managing multiple projects and flexibility when circumstances change

• A high degree of independence and initiative.

  • • Native German speaker and fluent in English, both written and spoken.
  • Languages: Proficiency in German and English, both spoken and written.

• The work includes both office work (approx. 80% of working time) and inspections of Class C/D/E clean rooms.

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