Quality Assurance Associate

Quality Assurance Associate # (m/w/d) freelance/in temporary employment for a project Bern Start date: immediately Reference number: 884671/1 Tasks ### • Support and consulting in the area of aseptic production and microbiological laboratories (no performance of activities within production or laboratory) • Checking and ensuring compliance with GMP requirements in production • Control, checking and documentation of work steps as well as review of processes in aseptic production • Participation in the training and (re-)qualification of employees in aseptic production • Support of production in case of problems during the entire production process with regard to compliance and risk assessment (standby service) • Support of deviations in the area of aseptic filling, incl. initial assessments • Support in defining the investigation strategy, incl. evaluation of technical assessments as part of investigations • Support of the Operations group in deviation investigation, including the definition of suitable corrective and preventive measures (CAPAs) to prevent the recurrence of similar deviations • Review of investigation reports in German and English and evaluation with regard to compliance and risk assessment Profile ### • Completed degree in natural sciences (Bachelor, Master or PhD) or equivalent qualification • GMP experience or knowledge from the pharmaceutical industry is an advantage • Analytical thinking as well as the ability to quickly grasp complex relationships and present them in a structured and understandable manner • Good understanding of the logical structure of texts and reports as well as the ability to critically question them • Team orientation, pronounced communication skills, assertiveness and the ability to work successfully with people at all hierarchical levels • Ability to switch between multiple projects and react flexibly to changing requirements • High degree of independence and initiative • German language skills at native level as well as very good English language skills in word and writing Benefits ### • Opportunity for further education and specialization in the area of quality assurance and aseptic production • Participation in internal and external inspections, which offers valuable insights and experiences • Work in a dynamic and innovative team • Support from experienced colleagues and access to modern technologies and methods • Direct influence on the quality and safety of production • Varied activities, from documentation and checking to participation in training and inspections • Opportunity for active co-design and improvement of processes • Support during the entire recruitment process by Hays