Quality Assurance Associate

CTC is a specialized search and recruitment partner for the Life Sciences industry, serving clients and candidates since 1997. We enable careers by connecting talented professionals with meaningful opportunities, and we support our clients in engaging, retaining, and developing the right talent when needed.

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 an initial 1 year contract position (with the possibility of extension) at our client's headquarters in Bern.

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:
• Conducting initial assessments
• Supporting the definition of the investigation strategy, including the evaluation of technical assessments within the scope of the investigation.
• 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.
• 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 Swiss working/residency permit and/or Swiss/EU-Citizenship required;
• Degree in a scientific field (Master, PhD).
• Several years of QA experience within a pharmaceutical company and GMP environment
  .
• Experience with deviation management, change management, quality on the floor.
• Experience working 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.
• Willingness to travel to Bern (no longer than 1 hour).
• Native level of German and professional English
  , both spoken and written.