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