| Description: | Dako, now part of Agilent, offers an exciting and challenging IT Compliance Specialist position in an international growing organization. The IT Compliance Specialist will join the IT Compliance, QA & Security team located in Glostrup, Denmark. You will be responsible for IT software validation process in our company’s regulated product line and report in to the Manager of IT Compliance QA & Security. Your primary task: • Qualification and validation of dedicated Dako IT systems in compliance with FDA: o 21 CFR Part 820 – Quality System Regulation o 21 CFR Part 11 – Electronic Records and Electronic Signatures • Assess and implement relevant regulatory requirements related to IT systems • Change Control support • IT Procedure development, alignment and maintenance responsible • IT general documentation maintenance • Risk assessment and IT QA analyst • Perform IT General controls (FDA, SoX, Compliance) • Participate in internal and external audits • Perform training in Quality & Governance Processes | |
| Qualifications: | Your qualifications: • Bachelor Degree of Commerce with additional QA or IT modules or similar • Practice of implementing and maintaining 21 CFR Part 820 and 21 CFR Part 11 • Experience working with GAMP5 methodology is an advantage • Experience working in a complex global environment being audited by different regulatory bodies • Previous experience as participant in audits • 3-7 years of experience with IT QA related work, which includes managing and executing IT systems and software validations • Previous experience from working in a medical device or pharmaceutical environment preferred • Demonstrated good ability to work with users and team members in a global environment • Ability to support rapidly changing processes • Maintain uncompromised practise in stressful and critical situations • Fluent in Danish spoken and written • Good spoken and written English • Flexible Questions For further information about the position please contact recruiter Anja Dyppel tlf. nr. +45 36 95 33 12. Application This is a prioritized hire so please forward your application and CV as soon as possible via our online recruitment system. Agilent is an equal opportunity employer. About Dako, an Agilent Technologies Company: Dako, based in Denmark, is a global leader in tissue-based cancer diagnostics. Hospital and research laboratories worldwide use Dako’s reagents, instruments, software and expertise to make precise diagnoses and determine the most effective treatment for cancer patients. Dako, with 1,100 employees, operates in more than 100 countries. Dako became part of Agilent Technologies on June 21, 2012. www.dako.com. About Agilent Technologies: Agilent is the premier laboratory partner for a better world. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the insights they seek – so they can do what they do best: improve the world around us. Information about Agilent is available at www.agilent.com. | |
| Company: | Dako | |
| Business: | Agilent OF & Supply Chain | |
| Job Category: | Information Technology | |
| Job Sub-Category: | IT Solutions & Delivery Management | |
| Region: | Europe | |
| Country or Area: | Denmark | |
| State/Province: | Capital Region of Denmark | |
| Town/City: | Glostrup | |
| Shift: | Day Job | |
| Job Type: | Experienced | |
| Schedule: | Full-time | |
| Travel Required: | Occasional | |
| Duration (Temp Positions Only): | Not applicable | |
