Quality Engineer

Quality Engineer # (m/w/d) freelance/in temporary permanent employment for a project Bern Start date: immediately Reference number: 890733/1 Tasks ### • Technical preparation, moderation, execution and documentation of quality risk analyses for utility systems and contamination-control-relevant processes • Structured recording of hazards, root causes, existing controls, weaknesses, measures and residual risks in official-ready quality • Ensuring methodologically consistent, scientifically sound and data-based risk analyses according to GMP requirements • Moderating interdisciplinary workshops and bringing together different perspectives, clarifying critical questions and bringing about traceable decisions • Evaluation of technical, organizational and procedural control measures as well as derivation and tracking of suitable improvement measures including effectiveness assessment Profile ### • Completed studies in pharmacy, biotechnology, process engineering, chemistry, microbiology, engineering or comparable scientific-technical field • Relevant, profound experience in a GMP-regulated pharmaceutical environment, ideally with sterile production, aseptic manufacturing, utilities, qualification, validation, QA or contamination control • Sound knowledge in Quality Risk Management according to ICH Q9 and comparable risk-based methods • In-depth knowledge of EU-GMP requirements, especially Annex 1, and holistic, documented lifecycle-oriented strategies Benefits ### • Look forward to working in an international environment • Professional and trusting cooperation • Exciting, innovative environment with international flair