Inserat online seit: Veröffentlicht vor 18 Std.
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PbLocation: /b the actual location of this job is in Visp, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed. /ppThe Contamination Prevention Control (CPC) Environmental Monitoring (EM) team delivers critical GMP compliance outputs across the whole Visp site, including EM Batch Reports (part of the batch release process), PQ monitoring reports, periodic trend evaluations, microbiological house-flora reports and monitoring data assessments required to demonstrate and maintain a state of control. As a QA Specialist, you will strengthen data-driven quality oversight within environmental and utility monitoring, combining hands-on GMP expertise with a structured, data-informed approach to contamination oversight. You will take ownership of compliance-ready EM outputs and complex investigations, acting as SME in audits and inspections. /ppYou will contribute to how monitoring data is collected, analysed, visualised and used to support risk-based decisions and proactive contamination prevention. /ppbWhat you will get: /b /plipAn agile career and a dynamic work culture. /p /lilipAn inclusive and ethical workplace. /p /lilipCompensation programs that recognize high performance. /p /lipIn addition to a competitive salary, you can expect numerous lifestyle, family, and leisure benefits. Our full list of tailored local benefits can be found below. /ppBenefits in Visp: /pppbbWhat you will do: /b /b /p /plipAuthor GMP-compliant EM reports for EM and CU monitoring, integrating microbiological expertise, and site knowledge from investigations and facility walkdowns in support of CCS maintenance and decision-making. /p /lilipSupport the review of EM outputs for batch release and certification, coordinating with relevant stakeholders to ensure timely delivery in line with batch release requirements /p /lilipCombine knowledge from cleanroom and production walkdowns with data collected from various GMP Quality systems to identify trends and assess contamination control status. /p /lilipPresent and defend monitoring performance, deviations, and related actions as SME in audits and inspections. /p /lilipEnsure compliance with SOPs, GMP, and internal quality requirements. /p /lilipLead and support complex investigations across facilities and departments, using EM data and trends and contamination control knowledge to reach well-founded conclusions /p /lilipContribute to cross-departmental CCS status dashboards and other reporting and visualization tools. /p /lilipIdentify and implement continuous improvement opportunities within reporting workflows, including lean and 6S initiatives, to reduce manual effort, eliminate waste and increase process standardisation /p /lippbbWhat we are looking for: /b /b /p /plipUniversity degree (PhD/Master/Bachelor) in Biology/ Biotechnology/ Microbiology/ Chemistry/ Engineering or related field. /p /lilipStrong scientific and technical background ideally with microbiology and contamination control knowledge, including familiarity with environmental and utility monitoring programs. /p /lilipSolid knowledge of GMP and regulatory requirements, including experience writing audit-ready GMP documentation (SOPs, work instructions, trend reports). /p /lilipExperience presenting and defending GMP documentation and reports to auditors and inspectors in a regulated environment /p /lilipExperience with data science tools such as R and/or Python and/or experience with Power BI or Power Automate is an advantage. /p /lilipExperience with MODA, TrackWise, LIMS, or comparable GMP systems is preferred. /p /lilipAbility to work autonomously, take ownership of deliverables, and drive tasks forward independently while managing competing priorities across routine and strategic workstreams. /p /lilipStrong cross-functional collaboration and communication skills in English and preferrably in German. /p /lilipStructured, proactive, and solution-oriented working style. /p /lipbAbout Lonza /b /ppAt Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of. /ppInnovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board. /ppbReady to shape the future of life sciences? Apply now. /b /p Reference: R76806
