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Novo Nordisk is a global healthcare company with 89 years of innovation and leadership in diabetes care. The company also has leading positions within Haemophilia care, growth hormone therapy and hormone replacement therapy.
Post : QMS Specialist
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.
Candidate Profile
• 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
Additional Information
Experience : 5+ years
Qualification : University/equivalent degree (Engineering, Pharmacy, Biology, Chemistry, or similar)
Location : Bangalore, Karnataka
Industry Type : Pharma / Healthcare / Clinical research
Department : NN Quality GBS
End Date : 30th September 2024
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