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Customer Audit Manager / Senior QA Specialist 80-100% (f/m/d)

Lonza • Visp, Switzerland

Salary not disclosed

•Quality Assurance•Full Time
EnglishGerman

Location: Visp, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed. For our site in Visp we are looking for a Senior QA Specialist /Customer Audit Manager (f/m/d) with a strong scientific background and experience in GMP manufacturing. He/She is responsible for the planning, execution and documentation of all customer audits and for the management of internal audits (self-inspections) and paper inspections by regulatory authorities. The Audit Manager also supports the QA Management in the preparation, execution and documentation of on-site regulatory inspections. The Audit Manager has face-to-face contact with Lonza’s customers on a regular basis and is therefore a key person for Lonza’s business. What you will get:  An agile career and dynamic working cultureAn inclusive and ethical workplaceCompensation programs that recognize high performanceA variety of benefits dependant on role and locationThe full list of our global benefits can be also found on https://www.lonza.com/careers/benefits. What you will do: Planning, executing and documenting customer audits on the Visp siteResponding to customer requests for audit datesPlanning audits together with Lonza project teams, based on the customers’ agendasAccompanying the customer throughout the audit (plant tours, documentation review etc.)Presenting Lonza’s Quality systems to the customerDocumenting the customer audits in TrackWiseCoordinating the responses to audit observations with the project team and ensuring that the customer receives the responses within the given timelinesProviding KPI data to QA Management on a regular basisConducting internal audits (self-inspections)Scheduling, preparing and performing internal audits as per approved audit scheduleAgree on an appropriate CAPAs and monitor the implementation to a satisfactory conclusionSupporting QA management during regulatory inspectionsOrganizing of preparation meetings and SME trainingsSupport in Front Office/Back Office as requiredResponsible for QA aspects of paper inspectionsCoordinating with Regulator Affairs to provide all required documentsAnswering queries from regulatory authorities with respect to paper inspections What we are looking for: Academic degree in Chemistry/ Biotechnology/ Life Sciences etcExcellent communication skills in English and German (fluency in both languages is required)Professional appearance and attitude to establish and maintain excellent working relationship with customersExcellent verbal, written and interpersonal communications skillsExcellent organizational skillsAbility to work in partnership as an active member of a team and/or cross functional working groupsAbility to prioritize and manage work to meet timelines in a fast-paced environmentGeneral knowledge of manufacturing processes and analytical methodsCompetent level of general IT skill (e.g. MS Office) is requiredExperience in auditing chemical/biopharmaceutical processes is an asset About Lonza At 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. Innovation 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. Ready to shape the future of life sciences? Apply now.

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