Qms Specialist

By continuing to use and navigate this website you are agreeing to the use of cookies Accept ClosePress Tab to Move to Skip to Content LinkSearch by KeywordSearch by LocationLoading CategorySelect how often in days to receive an alert xc3 x97Select how often in days to receive an alert QMS SpecialistCategory QualityLocation Bangalore Karnataka INDepartment NN Quality GBSAre 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 element 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 accontable Global stakeholder mgt 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 DisclaimerIt 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 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