Skill Area:GxP Validation, Computer system Validation(CSV) Main Technology:CSV Mandatory Skills:CSV, Quality management system(QMS), Audit Handling Optional Skills:(Good to Have Skills) - Stakeholder management Roles Responsibilities:as in trail email.Key responsibilities main job The IT Validation and Compliance Partner is responsible for defining validation strategy and activities to support the Novo Nordisk S.3.01 Manage IT process. The role is applicable in several GxP and Business Critical areas such as Computerised Systems, Computerised Equipment, Infrastructure and Robotic Process Automation (RPA) as well as within Emerging Tech such as Artificial Intelligence (AI) Machine Learning (ML), both in the development and operation phase. Key stakeholders for collaboration are DevOps-, Project- team, IT QA, LoB, IT Security. The role requires the ability to apply Critical thinking to overcome barriers - and the ability to partner with stakeholders to ensure the system controls and validation efforts applied are balanced to the criticality of the business context. The IT Validation and Compliance Partner is focused on assisting DevOps teams to work on system releases and maintaining the validated state. This is done through the work of the below areas where the role is either accountable or responsible depending on the context. The main responsibility as IT Validation and Compliance Partner covers implementation planning and reporting, supplier assessment, risk and impact assessments, requirements and specifications, design review, verification, protocols and reports, system releases. To maintain the validated state of the system and ensure the system remains fit for intended use, the IT Validation and Compliance Partner can assist in audits if relevant, work on change management, incidents, periodic evaluations, user reviews and eventually retirement planning. Core competencies: Categories in headline the key competencies that is required to perform the role Extensive knowledge about IT service management to manage and scope the validation activities with focus on ability to operate and maintain the system Extensive knowledge about NN QMS and good practices (GxP), to create awareness around quality processes and highlight risks to drive informed decisions. Critical thinking and ingenuity to ensure manual processes are automated where possible, such as test management, configuration, document generation etc. Quality mindset to create and scope short and on point release cycles balancing quality and speed to ensure real value is delivered to stakeholders. Considerate and mindful to nurture and promote a healthy social working environment. Stakeholder management and communication skills, to ensure timely involvement of stakeholders such as LoB, IT QA, Business Owners, Enterprise Architects, Solution Architects, IT Security etc. Named Job Posting? (if Yes - needs to be approved by SCSC)Additional Details

Global Grade :C

Level :To Be Defined

Named Job Posting? (if Yes - needs to be approved by SCSC) :No

Remote work possibility :No

Global Role Family :To be defined

Local Role Name :To be defined

Local Skills :CSV, Quality management system(QMS), Audit Handling;GxP

Languages Required::ENGLISH

Role Rarity :To Be Defined

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Novo Nordisk - CSV testing - Bangalore - C1