Job Details
Job descriptionJob Title: Senior IT Quality AdvisorDepartment: IT QualityJob Location: Bengaluru 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 Are you excited about implementing the IT Quality Assurance (QA) at Novo Nordisk Then we might have the right position for you We are looking for a skilled colleague who will be instrumental in setting the direction for automated deployment, testing and swift delivery of qualified Cloud services in a highly regulated (GxP) environment Sounds exciting - Apply now and join a growing team, working in an international environment The Position As a Senior IT Quality Advisor, you will ensure the IT QA activities for regulated (GxP) IT systems/services/projects in your portfolio are delivered successfully Provide IT QA subject matter expert (SME) support for System/Service/Project Managers.
You will also be entrusted with the following responsibilities:
- Together with the Cloud Architects and Cloud Engineers you will be a key contributor in setting the direction for the process around releasing automated deployment, self-service workload provisioning, requirement testing and continuous delivery of new qualified Cloud services in our highly regulated (GxP) environment You will be a part of the IT Quality organisation, but in your daily work you will be working closely with colleagues from our Cloud area, ensuring timely delivery of Cloud services
- Ensure fulfilment of Quality Assurance (QA) responsibilities and IT QA support for IT systems/services/projects in your portfolio (as agreed with QA management), approval of quality documents, advise on quality matters, and assistance in closing compliance gaps found in audits and inspections
- Provide coaching and give direction for ITQC and SME employees in quality and compliance tasks/issues or stakeholder matters
- Ensuring that IT systems/services are developed and maintained in compliance with internal and international standards and regulations.
Advising IT projects in quality matters and ensuring that the IT systems/services will pass inspections from the authorities without problems - You will be an independent, self-motivated and curious person, who can apply Infrastructure knowledge and actively engage conversations with Infrastructure stakeholders, architectures and leadership team
Qualification
- 12 years of experience along with MSc, B.
Sc or similar graduate degree - 3+ years of practical experience in GLP/ GMP/ GCP/ pharmacovigilance areas
- 3+ years of experience working with Infrastructure, qualification, implementation, and maintenance of
- Infrastructure, Cloud infrastructure
- Experience in automated deployment, testing and continuous delivery of Cloud services
- 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 Working At Novo Nordisk We are a proud life-science company, and life is our reason to exist We're inspired by life in all its forms and shapes, ups and downs, opportunities, and challenges.
For employees at Novo Nordisk, life means many things - from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work Ultimately, life is why we're all here - to ensure that people can lead a life independent of chronic disease Contact If you believe you are a match for the above requirements and are willing to take up the role, please apply here with our online application tool Deadline 11th April 2023 We commit to an inclusive recruitment process and equality of opportunity for all our job applicants At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world.
We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in Together, we're life changing