Job Location: Bangalore
In Novo Nordisk we aim for a quality mind set in everything we do, have high user focus, and strive to achieve strong business results.
About the department
CVT CoE is the unit responsible for compliance management of more than 30 global IT systems at Novo Nordisk. The systems are used on a global scale by many areas of the business, including R&D, Patient Safety etc. and are critical to the execution of key business process such as development, manufacturing, sales, finance, etc. This unit is responsible for validating these systems and maintaining the validation status.
The position
As an Advance Business Analyst, you will be responsible for performing various tasks related to Computerized System Validation (CSV) including defining risk-based validation strategy & deliverables and develop plans, execute, and deliver the services with acceptable service evaluations. You will be able to perform CAPA and RCA using 5 x Why approach or any similar approach. You will be trusted to Provide compliance consulting for the IT projects and deliver compliance deliverables with respect to CSV. You will play a key role to manage test execution and reporting and perform stakeholder management as a part of delivering services involving multiple stake holders with diverse interests, knowledge, cultural background, and personality. You will be responsible to manage multiple concurrent tasks and be flexible and participate in audits and inspections related to the project supported including finding solutions to compliance gaps identified in audit/ inspections.Your responsibly will also include to perform compliance related tasks provided as services from the department and excellence in CSV understanding. Across your tasks you will responsible for Service Operative-Compliance Services and Service Operative-Periodic Reports Services.
Qualifications
MCA, M.Sc., B.SC. or similar graduate degree in relevant field (Computer Science, IT Quality)
Preferred to have Industry recognized ITIL and ISO quality management certification
Excellent communication skills in English and comfortable working with different cultures
Minimum 7+ years of experience in working in a service level-based organization/ pharmaceutical industry preferably in the IT quality domain.
Minimum 3+ years of practical experience in GxP areas with exposure to regulatory affairs.
Min 4+ years in performing RCAs, CAPA and any other relevant IT quality assurance activities.
Excellent knowledge on regulatory requirements as well as internal requirements to keep systems within responsibility in compliance.
Broad knowledge of basic IT technologies to be able to understand, and challenge decisions made by IT QA.
Very good understanding of GAMP 5
Working at Novo Nordisk
In Novo Nordisk, you will be met with trust, interesting challenges and rich opportunity for personal and professional growth. You will be investing your unique skills in an environment focused around a competent sharing of knowledge, and where your talent and experience is valued. We are proud to use our dedication and our capabilities to make a difference for millions of people around the world.
Contact
For further process, please click “Apply” and follow the instruction.
Deadline
15 February 2022.
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.
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