Advanced IT Quality Advisor

Department : IT Quality
Does your motivation come from challenges and working in a dynamic environment? Do you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is essential? Do you have a can:do attitude with continuous improvement as one of your career objectives? Then we might have the right position for you. Apply now and join a growing team, working in an international environment.
The Position
As an Advanced IT Quality Advisor, you will coordinate the IT QA activities for IT systems/services/projects in own portfolio, Providing IT QA subject matter expert (SME) support for System/Service/Project Managers, ITQCs and SMEs in optimal use of quality related processes (including the use of external partners) to meet business challenges and reduce waste. You will also be entrusted with the following responsibilities:
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Ensure fulfilment of Quality Assurance (QA) responsibilities and IT QA support for IT systems/services/projects in own portfolio (as agreed with QA management), hereunder approval of quality documents, advise on quality matters, and assistance in closing compliance gaps found in audits and inspections.
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Provide coaching and set direction for ITQC and SME employees in quality and compliance tasks/issues or stakeholder matters.
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Fulfilment of IT QA responsibilities for the systems/services and projects in own portfolio.
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Ensuring that IT systems/services are developed and maintained in compliance with internal and international standards and regulations. Advising IT projects in quality matters.
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Ensuring that the IT systems/services will pass inspections from the authorities without problems.
Qualifications
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You will be holding a bachelor 's degree in relevant subject with 9 : 11 years of experience having 3 years of practical experience in GLP/ GMP/ GCP/ pharmacovigilance areas.
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3 practical experience as quality responsible/project manager.
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3 years of practical experience with IT QA work in GxP areas.
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Must have Software Development Life Cycle (SDLC) review and approval exposure along with experience in IT system risk assessment.
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Must have 21CFR Part 11 and GAMP 5 exposure.
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Good to have experience in periodic review and approval, Change request Management, Deviation Management, IT Vendor Audit Management and Safe Agile.
About the department
ITQA is an extended unit of Denmark that supports different system/service portfolios across Global IT and IO affiliates. We are responsible for managing ITQA tasks for corporate GxP IT systems, RPA and parts of PS infrastructure. We focus on providing high:quality services using simple and agile processes to ensure compliance.
ITQA team leverages the knowledge and experience of IT and quality assurance to provide three main services: Quality Management, Quality Assurance and Quality Support.
Working at Novo Nordisk
Novo Nordisk is a leading global healthcare company with a 100:year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 63,000 employees around the world. We recognize the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk, were working toward something bigger than ourselves, and its a collective effort. Join us Together, we go further. Together, were life changing.
Contact
To submit your application, please upload your CV online (click on Apply and follow the instructions).
Apply Now
Deadline
8 May 2024.
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Job Type: Permanent