Quality Assurance Associate - 7155

pCTC 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. /ppOur 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. /ppWe are seeking a highly skilled bQuality Assurance Associate /bfor an initial b1 year contract /b position (with the possibility of extension) at our client's headquarters in Bern. /ppbMain Responsibilities: /b /pulliSupport and consulting in the area of aseptic manufacturing and microbiological laboratories (no performance of activities within manufacturing or the laboratory) /liliReview and ensure bcompliance /b with bGMP requirements in production /b /lilibControl, review, and documentation /b of work steps, review of processes in aseptic production. /liliParticipation in the training and (re)qualification of aseptic production employees /liliSupport for deviations in the area of aseptic filling: /liliConducting initial assessments /liliSupporting the definition of the investigation strategy, including the evaluation of technical assessments within the scope of the investigation. /liliSupporting 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. /liliReviewing the investigation reports in bGerman and English /b and assessing them for compliance and risk assessment. /liliParticipation in the preparation of deviations within the scope of internal and external inspections. /liliSupport in reviewing specification documents /li /ulpbQualifications Experience: /b /pullibRelevant Swiss working/residency permit and/or Swiss/EU-Citizenship required; /b /liliDegree in a scientific field (Master, PhD). /lilibSeveral years of QA experience /bwithin a bpharmaceutical company /b and bGMP environment /b. /liliExperience with bdeviation management, change management, quality on the floor. /b /liliExperience working with bQMS /b. /liliStrong enthusiasm, analytical thinking, and effective communication skills. /liliPrecise and reliable work approach with the ability to prioritize effectively. /liliFlexibility and ability to work independently as well as in a team, maintaining composure in fast-paced environments. /liliWillingness to travel to Bern (no longer than 1 hour). /lilibNative level of German and professional English /b, both spoken and written. /li /ul #J-18808-Ljbffr