To drive our continuous organic growth, we are constantly looking for highly qualified professionals. To strengthen our new Global Quality Unit, we are looking for a dedicated QA CSVManager (f/m/d) 80-100% in a newly created position.Your tasksEnsure computerized systems are appropriately validated according to Bachem internal standardsReview and approve CSV documents (e.g. validation plan/report, URS, FS, risk assessments, test protocols and test reports)Guide and support teams implementing new projects to define and implement the appropriate way of CSVJoin future IT-related projects as QA representativeOversee and support the life-cycle management of validated software systems incl. change management, periodic review, and system retirementProvide training on CSV policies, SOPs, to internal stakeholders e.g. project team members, system ownersParticipate in customer audits and authority inspections as CSV subject matter expertSupport the re-/evaluation of suppliers for software solutionsMaintain a close liaison with internal stakeholders e.g. Global IT, OT, MSAT, Quality ControlYour profileBachelor's degree or equivalent qualification in information technologies, life sciences (chemistry, engineering) or similarAt least 3 years practical experience in computerized system validation in cGMP regulated environments in Quality Management departments, IT departments, or equivalent Consultant positionsKnowledge of cGMP regulations related to CSV including CFR 21 Part 11, EU GMP Annex 11 and GAMP standardsDetail oriented with the ability to troubleshoot and resolve problems.Hands-on when requiredAbility to effectively work in a fast-paced, deadline driven work environmentAbility to work independently and manage one's timeAbility to communicate in a proactive and solution-focused mannerExperience in working in cross-functional teamsFluency in English (spoken and written), German also preferredOur offerA dynamic and rapidly growing working environment with internal development opportunitiesFlexible working hours with the possibility of home officeEmployee development through numerous internal and external training opportunitiesAs standard, Bachem AG pays 60% of the pension fund contributionsAccess to the Swibeco benefits platform with many discounts at external partnersFresh, healthy, and varied food in our staff restaurantA wide range of free sports activities on the Bachem CampusWould you like to drive innovation together with us?Have we aroused your interest? Then we look forward to receiving your complete application documents via our application portal.Learn more about the Bachem Group and be inspired by our inspiring working environment at our location in Bubendorf!