Job Description

Job description Business Unit - Legal Compliance and Quality Does your motivation come from challenges and working in a dynamic environment? Is your ambition to create visible results? Are you enthusiastic about understanding the business and bring

Job description Business Unit - Legal Compliance and Quality Does your motivation come from challenges and working in a dynamic environment Is your ambition to create visible results Are you enthusiastic about understanding the business and bringing attention to key business challenges Then we might have the right position for you. Apply now with your latest profile and you may be our newQuality Associatefor our Legal Compliance and Quality Business Unit based atBengaluru. The Position The position holder is responsible to Ensure QMS (Quality Management System) in affiliate is in compliance to Novo Nordisk and external requirements and manage affiliate Quality Associate (QA) activities. and Repackaging : You will be responsible for the content responsible for Indian affiliate, approval, uploading of local procedures in Quality Docs. Handling reviews and comments on procedure drafts. SOP (Standard Operating Process) expert in the affiliate and approve SOP deviations. Maintenance and distribution of procedures. Review and approve the Batch documentation of Repackaging. Validation and Calibrations : You will be responsible to review and approve the validation protocol and report for all the temperature distribution study conducted in the distributor's sites and also of calibration certificates of cold rooms conducted at distributor's sites as part of validation. Quality Control (QC) and Quality Management Review (QMR): You will verify clinical safety reports and post marketing safety reports before reporting to concerned Indian regulatory authorities. QC of logging of customer contacts. Prepare data and inputs for QMR. Prepare MOM (Minutes of the Meeting) with the identified Action points- Implement and follow-up for the completion of action points. Audits: You will act as GDP Lead Auditor and prepare Audit plan and conduct audit external suppliers. Ensure Quality compliance with Audits and Authority Inspections. Follow up and closure of audit findings issued during HQ and Local Audits. Warehouse and Storage : You will do Quality Oversight for NN licensed warehouse and product storage areas. Quality Oversight on storage and product movements as per NN QMS and License Requitements in HO (Refrigerator Room). Qualifications 6 + years of experience in the pharmaceutical industry About the department Our main goal is to make learning a competitive advantage for Novo Nordisk. And it is our aspiration to make learning attractive, relevant and easy to access for all functions and all our 43,000 colleagues across the world. Together with line of business, we define learning needs and design high-quality programs, academies and off-the-shelf training based on newest research and proven best practice, always focusing on what the business needs. 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 toward 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 and motivational letter online (click on Apply and follow the instructions). Deadline 18th September 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.