Advanced IT Quality Advisor

1 month ago

Bengaluru, India Novo Nordisk AS Full time


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:

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. Provide coaching and set direction for ITQC and SME employees in quality and compliance tasks/issues or stakeholder matters. Fulfilment of IT QA responsibilities for the systems/services and projects in own portfolio. Ensuring that IT systems/services are developed and maintained in compliance with internal and international standards and regulations. Advising IT projects in quality matters. Ensuring that the IT systems/services will pass inspections from the authorities without problems.
 

Qualifications

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. 3+ practical experience as quality responsible/project manager. 3+ years of practical experience with IT QA work in GxP areas. Must have Software Development Life Cycle (SDLC) review and approval exposure along with experience in IT system risk assessment. Must have 21CFR Part 11 and GAMP 5 exposure. 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.
 

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