QMS Specialist

Department: NN Quality GBS

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 work together with our Product supply (GMP) areas on QMS activities, specifically Deviation and Change Control. 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. One of the key elements of the role will be to measure performance and drive improvements in the deployment of the QMS elements.

About the department
Novo Nordisk Quality GBS was established in May 2015. We are responsible for supporting and development of overall quality services, such as training coordination, content control, digital solutions, quality and compliance management and records management for various units within Novo Nordisk. Here, you will be a part of an ambitious, dynamic and global team consisting of over 100 employees who ensure high quality as well as fit-for-purpose processes for the entire value chain from research to market. We make quality easy, simple and understandable.

The position
As a QMS Specialist at Novo Nordisk, you will:

• Drive compliance support to product supply areas (mainly focusing on GMP/GLP) & Support Deviation and CR handling set-up fit for purpose in NN
• Be the subject matter expert for Deviation and CR handling
• Deviation handling expert (Deviation Responsible) - handled deviations, classify deviations, perform thorough Root Cause Analysis, initiate and implemented CAPA, support periodic review for shop floor process
• 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/CR.
• Responsible for identifying and driving improvement projects within Deviations, CR handling, and other relevant processes, together with the process manager
• Derive KPIs for the QMS and measure performance and put in place improvements.
• Responsible to drive cross-functional meetings across stakeholders/teams
• Timely follow-up on defined goals/tasks
• 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, 9-16 years of experience, 4-5 years of experience in compliance and QMS related activities
• Trained and worked according to international principles.
• Experience in GMP
• Good understanding and experience of QMS process
• Ability to communicate effectively
• Exposure to Audits/Inspections
• Experience with Change Request handling
• Strong communication skills, to have a challenging discussion with multiple stakeholders
• Proactive and accountable
• Global stakeholder management and cross-cultural collaboration
• Worked within cLEAN/LEAN projects.
• Experience with GMP/GDP on operational level

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
18th 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 training. 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 the communities we operate in. Together, were life-changing.

Locations
Bangalore, Karnataka, IN