YOUR TASKS AND RESPONSIBILITIES

• Support of plants with regard to pharmaceutical-technical questions in the area of quality assurance as well as ensuring that the batches are produced in accordance with the approval and GMP requirements
• Ensuring the correct evaluation of deviations, including the investigation of causes, in accordance with global GMP and legal requirements within the specified time limits
• Assessment and closing of CAPAs, corrections and effectiveness checks
• Evaluation of global and local CMC changes regarding products and processes
• QA representative (m/f/d) for process validation and cleaning validation
• Evaluation and approval of risk analyses for, among other things, the production and cleaning processes used, for deviations and products using common risk management systems
• Review and approval of master manufacturing specifications

WHO YOU ARE

• University degree in pharmacy or life sciences with PhD, preferably with license as pharmacist (m/f/d)
• Long-term experience in the GMP environment (e.g. quality assurance, production, analytics) with a pharmaceutical manufacturer
• Very good knowledge of GMP-compliant pharmaceutical production of solids and its technical principles
• Very good cooperation ability with interface partners (e.g. production, quality control, supply chain, MS&T)
• Experience in analytics and pharmaceutical technology and solid knowledge in pharmaceutical production techniques
• Very good knowledge of MS Office applications
• Excellent communication and negotiation capabilities as well as deep commitment to enhance quality standards
• Good judgment, stress resistance and assertiveness
• Fluent in German and English, both written and spoken