QA Associate (6489)

Quality Assurance Associate – 6489 ADAOur 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 skilledQuality Assurance Associatefor a 12-month contractposition 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 mandatoryMain 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:oConducting initial assessmentsoSupporting the definition of the investigation strategy, including the evaluation of technical assessments within the scope of the investigation.oSupporting 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.oReviewing 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 documentsQualifications & Experience:Relevant working/residency permit or Swiss/EU-Citizenship requiredEducational 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 Control1-2 years of experience with QMSStrong 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. #J-18808-Ljbffr