Job Description

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Advanced Operations Analyst II

Category: Digital & IT

Location:

Bangalore, Karnataka, IN

Department Name - GITO CCI (Cloud & Corp Infrastructure)

At Novo Nordisk, we strive to be at the forefront of digital healthcare and to succeed with this, we need many bright minds. Working directly or indirectly with all parts of Novo Nordisk Globally, you will play a significant part in leading Novo Nordisk towards the future of digital healthcare securely. We are looking for an Advanced Operations Analyst II for our GITO CCI (Cloud & Corp Infrastructure) unit. Join a growing team, working in an international environment. Apply now!

About the department

Cloud and Corporate Infrastructure (C&CI) area, part of Global IT Operations (GITO) - a department with 400+ employees distributed across more than 25 countries, managing our Cloud Services, Infrastructure Services, Operations, IT Support, Major Incident Management and Digital Workplace Services. The Cloud and Corporate Infrastructure is an area consisting of 100+ people in 10+ Product teams with highly skilled and dedicated employees. We have a strong focus on teamwork and collaboration, and we work in a truly global setup with colleagues located all over the world. In C&CI we are globally responsible for all Novo Nordisk Cloud (Private and Public), and Corporate Infrastructure (Network and Connectivity) Services.

The Position

As an Advanced Operations Analyst II, you will be responsible for GxP/ business IT systems validation and compliance with QMS requirements. Ensure quality and compliance of GXP IT Infrastructure system, you will be entrusted with the below responsibilities:

• Review validation plan/report, URS, FS, TDS, Test plan/report, Qualification Protocol (IQ, OQ, PQ), test cases and TRM.
• Handle the change request and supervising the day-to-day usage, operation and maintenance of the IT system.
• Co-ordinate at various stages of IT project to provide support for Internal audit / Inspection and facilitating the closure of the identified Audit/Inspection findings.
• Supporting IT solution qualification activities e.g., creation and maintenance of the qualification documentation. Ensuring that IT services are following relevant internal and external requirements.
• Working in the agile framework as part of a product team and work towards the team\'s goals, based on Product Owner and Business Owner\'s requirements.

Qualifications

• Bachelor or Masters in relevant field with overall 10 years in IT and minimum 7 to 9 years working experience in GxP requirements within the pharmaceutical or other relevant industry.
• Should have strong background within computer system validation (Domain experience in GXP, 21 CFR part 11, GAMP 5, Annex 11, AL-COA, Data Integrity and other compliance requirements adherence.
• Strong experience in stakeholder management, Release Management - planning, execution, and benefit realization.
• Should have experience in Life Sciences IT Compliance/CSV/ITQA and Data Integrity with extensive experience in FDA (GxP, 21 CFR Part 11), and other regulations.
• Good experience in Validation activities related to IT Infrastructure, Lab Systems, Manufacturing systems (DCS, PLC, SCADA) and service desk compliance.
• ITIL processes especially Change, Release and Configuration management.
• Good to have working experience with Agile framework.
• Ability to represent NN in relations with internal and external stakeholders including Suppliers and Authorities.
• Ability to analyse and solve complex issues in a timely and structured manner.

Working at Novo Nordisk

Novo Nordisk is its people. We know that life is anything but linear and balancing what is important at different stages of our career is never easy. That\'s why we make room for diverse life situations, always putting people first. We value our employees for the unique skills they bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk is working towards something bigger than ourselves, and it\'s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 40,000 employees. Together, we go further. Together, we\'re life changing.

Contact

To submit your application, please upload your CV online (click on Apply and follow the instructions).

Deadline

21st December 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.

Novo Nordisk