AddressQuality Process Specialist
Category: Quality
Location: Bangalore, Karnataka, IN
Department: Operations Quality Consulting & Projects
Are you passionate about ensuring compliance and regulatory requirements? Do you have experience in driving process efficiency projects? We are looking for a Compliance Support professional to join our team and support our International Operations (IO) and North America Operations (NAO). If you are detail-oriented, have strong analytical skills, and are ready for a new challenge, read on and apply today for a life-changing career. As part of the role you will analyze business needs to identify the requirements for change or improvements to processes and tools while supporting fundamental changes of processes to eliminate inefficiencies and improve effectiveness and quality. Another key element of the role will be to measure performance and drive improvements in the deployment of the QMS elements.
The Position
As a Quality Process Specialist at Novo Nordisk, you will:
- Drive compliance support to International Operations (IO) and North America Operations (NAO) & Support Deviation, validation, and CR handling set-up fit for purpose in IO and NAO.
- Be the subject matter expert for Deviation, CR handling, and Cold chain equipment Qualification.
- Analyze data of Deviations and Change Requests handled by the team and identify meaningful trends, Drive process efficiency projects based on identified trends.
- Responsible for data analysis of Deviations in Operations and handled by the team.
- Responsible for identifying and driving improvement projects within Deviations, cold chain validation, CR handling, and other relevant processes.
- Derive KPIs for the QMS and measure performance and put in place improvements.
- Maintain specialist knowledge and awareness related to delivery areas assigned.
Qualifications
To be successful in this role, we are looking for a candidate with the following qualifications:
- University/equivalent degree (Engineering, Pharmacy, Biology, Chemistry, or similar)
- Overall, 9-12 years of experience, Mpharm/MSc: and 7+ years of relevant experience, Bpharm/BSc: and 9+ years of relevant experience
- Trained and worked according to international validation principles.
- Experience with Change Request handling
- Worked within cLEAN/LEAN projects.
- cLEAN certified.
- Leadership experience.
- Experience with GMP/GDP on operational level
About the Department
The Quality Process Specialist is part of the OQCP (Operations Quality Consulting and Projects) team, which is an extended unit from Denmark supporting 80+ affiliates areas across Novo Nordisk with Deviations, Change Controls and Qualification processes. At OQCP, we focus on business-critical issues that may have an impact on NN’s license to operate and inspection readiness. As a member of the OQCP team, you will play a vital role in supporting the implementation and maintenance of the Novo Nordisk Quality Management System in affiliates functions.
Working at Novo Nordisk
At Novo Nordisk, we are driving change to defeat diabetes and other serious chronic conditions. Our treatments today are benefiting millions of people living with diabetes, obesity, and rare blood and endocrine diseases. From our labs to our factory floors, we are discovering and developing innovative biological medicines and making them accessible to patients throughout the world. Since the company was founded in Denmark more than 100 years ago, we have been translating the unmet medical needs of people living with serious chronic diseases into innovative medicines and delivery. Our focus is on these diseases, which affect hundreds of millions of people and are among the most urgent global health challenges. By combining our innovation and commercial excellence, we draw upon insights from patients and partners to transform bold ideas into life-saving and preventive medicines. Our ambition is to take the lead in each of these areas, driving change with an unfailing belief that it can be done.
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
Apply on or before: 22nd March 2024
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.
