<div class="jobListItemText"><span><span><strong><span><span><span><span>IT Quality Assurance (QA) and Computer Systems Validation (CSV) Manager</span></span></span></span></strong></span></span><br/><br/><span><span><span><span><span><span>We are currently looking for </span></span></span></span><span><span><span><span>IT QA and CSV Manager </span></span></span></span><span><span><span><span>for one of our clients in </span></span></span></span><span><span><span><span>medical industry</span></span></span></span><span><span><span><span>. </span></span></span></span><span><span><span><span>As part of the corporate IT team, you will ensure the software quality and computer systems are meeting the required standards and comply with laws and regulations.</span></span></span></span></span></span><br/><br/><br/><span><span><strong><span><span><span><span>Your main tasks will be:</span></span></span></span></strong></span></span><br/><ul><li style="text-align:justify;margin:0cm 0cm 0cm 36pt;"><span><span><span><span><span><span>Ensure that the software and IT systems </span></span></span></span><span><span><span><span>perform</span></span></span></span><span><span><span><span> properly and meet the required quality standards.</span></span></span></span></span></span></li><li style="text-align:justify;margin:0cm 0cm 0cm 36pt;"><span><span><span><span><span><span>Ensure that the computer systems are compliant with laws and the internal and external regulatory requirements.</span></span></span></span></span></span></li><li style="text-align:justify;margin:0cm 0cm 0cm 36pt;"><span><span><span><span><span><span>Identify potential risks related to computer systems and implement strategies to mitigate these risks.</span></span></span></span></span></span></li><li style="text-align:justify;margin:0cm 0cm 0cm 36pt;"><span><span><span><span><span><span>Create, maintain, review, and approve the documentation of the validation process.</span></span></span></span></span></span></li><li style="text-align:justify;margin:0cm 0cm 0cm 36pt;"><span><span><span><span><span><span>Organize and oversee series of tests to prove the systems perform correctly and reliably as expected.</span></span></span></span></span></span></li><li style="text-align:justify;margin:0cm 0cm 0cm 36pt;"><span><span><span><span><span><span>Collaborate with authorities, auditors, customers and suppliers within the CSV and IT QA area. </span></span></span></span></span></span></li><li style="text-align:justify;margin:0cm 0cm 0cm 36pt;"><span><span><span><span><span><span>Validate computer systems according to GxP and GAMP guidelines to ensure used systems in these processes are reliable and compliant.</span></span></span></span></span></span></li><li style="text-align:justify;margin:0cm 0cm 0cm 36pt;"><span><span><span><span><span><span>Continuous improvement of IT services and CSV processes according to the Information security standards</span></span></span></span><span><span><span><span>.</span></span></span></span></span></span></li></ul><br/><br/><span><span><strong>To enjoy this role, you should have/be:</strong></span></span><br/><ul><li style="text-align:justify;margin:0cm 0cm 0cm 36pt;"><span><span>Degree in science or technical related field.</span></span></li><li style="text-align:justify;margin:0cm 0cm 0cm 36pt;"><span><span>Trained in Quality Assurance and Computer Validation Systems.</span></span></li><li style="text-align:justify;margin:0cm 0cm 0cm 36pt;"><span><span>Working experience in medical industry. </span></span></li><li style="text-align:justify;margin:0cm 0cm 0cm 36pt;"><span><span>Knowledge of Q systems and IT standards such ISO 27001, ISO 80002-2 and other related standards.</span></span></li><li style="text-align:justify;margin:0cm 0cm 0cm 36pt;"><span><span>Excellent interpersonal skills.</span></span></li><li style="text-align:justify;margin:0cm 0cm 0cm 36pt;"><span><span>Fluent in German (C1+) and English.</span></span></li></ul><br/><br/><span><span><span><span><span><span>We look forward to receiving your application and should you have any further questions, please reach out to Jana Miloudi at E-Mail schreiben / +41 (0)41 588 12 83.</span></span></span></span></span></span><br/></div>