IT Validation & Compliance Specialist I

Department: Site Collaboration Solutions (DD&IT Development)
Are you passionate about IT validation and compliance? Do you have a knack for ensuring systems meet regulatory requirements? We are looking for an IT Validation & Compliance Specialist I to join our Site Collaboration Solutions team at Novo Nordisk. If that sounds like you, read on and apply today for a life-changing career.
About the department
DD&IT (Digital, Data & IT) Development is the unit responsible for over 70 DD&IT systems at Novo Nordisk including the operation, maintenance, support and development of these systems. The systems are used on a global scale by all areas of the business from R&D to Sales and are critical to the execution of key business processes such as development, manufacturing, sales and submissions. This position is anchored within DD&IT Development unit in DD&IT GBS India in the department Site Collaboration Solutions. The Site Collaboration Solution department manages IT systems responsible for setting up trials, distributing relevant documents to clinical sites. The team which is basically composed in an ART set up also ensures interactions with clinical sites, investigators and clinical staff with regards to different IT support as well as development.
The position
As an IT Validation & Compliance Specialist I at Novo Nordisk, you will have the following responsibilities:

• Performing activities related Computer System Validation (CSV)/ Computer Software Assurance (CSA) in line with Novo Nordisk Quality Management System (QMS) like validation for GxP Computerized Systems/ Computerized Equipment both in project and operations phase. Service Management responsibility for multiple projects.
• Participate in audits and inspections including finding solutions to compliance gaps identified in audit/ inspections.
• Managing yearly periodic review reports, upkeeping audit readiness checklist and all system level documentation (e.g. risk assessments, plans, reports, requirements and specifications) up to date.
• Responsible for preparing the Release plan for releases and driving all the release related activities.
• Define test strategy, manage test execution, review and reporting in line with Software Testing Life Cycle (STLC) including handling validation deviations. Perform CAPA and RCA using 5 x Why/ approach or any similar approach.
• Define a risk-based validation strategy & execute in line with Novo Nordisk QMS. Act as an SME for Validation activities and execute the validation strategy both in Agile and V Model as necessary.

Qualifications
To be successful in this role, you should have:

• Bachelors or Masters in relevant field with minimum 8 to 10+ years in the IT or equivalent industry and minimum 4+ years of GxP Validation& CSV /Testing experience in working with pharmaceutical requirements.

• Experience in Risk assessment (IT Risk Assessment related to: Business Process, Solution, Data Integrity, IT Security, Functional, Supplier) and exposure to Test management tools such as HP ALM.
• Experience with supplier assessment, deviation handling, change management is required and good understanding of GAMP 5 and various Regulatory requirements including CFR part 11, EU Annex 11.
• Expert in performing validation activities for complex projects and ability to represent NN in relations with users and external stakeholders.
• Good to have experience in Agile methodology & waterfall methodology, usage of Azure DevOps (ADO) etc.
• Experience in drafting test cases & reviewing test cases and approving test cases in Leapwork (Good to have) or any other automated test management tool.
• Good to have Industry recognized ITIL and Scaled Agile Framework (SAFe) 5 Practitioner.
• Excellent interpersonal and communication skills including verbal and written communication. Ability to represent NN in relation with users and external stakeholders.
• Minimum 5+ years in performing RCAs, CAPA and any other relevant IT quality assurance activities.

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, we're working toward something bigger than ourselves, and it's a collective effort. Join us! 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).
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Deadline
30 Sep 2024.
Disclaimer
It has been brought to our attention that there have recently been instances of fraudulent job offers, purporting to be from Novo Nordisk and/or its affiliate companies. The individuals or organizations sending these false employment offers may pose as a Novo Nordisk recruiter or representative and request personal information, purchasing of equipment or funds to further the recruitment process or offer paid trainings. Be advised that Novo Nordisk does not extend unsolicited employment offers. Furthermore, Novo Nordisk does not charge prospective employees with fees or make requests for funding as a part of the recruitment process.
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.