Novo Nordisk looking for Senior Quality Advisor

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 : Senior Quality Advisor

Job Description
The Position
As a Senior Quality Advisor, you will be responsible to handle and approve deviations/change requests for quality/safety/regulatory processes. Furthermore, you will participate and contribute in audits/inspections as “Quality Advisor”. As a process QA delegate, you will carry out QA activities for the processes as per SOPs, review changes to the Quality management System (QMS), handle and approve QC documents and drive QMS improvement initiatives. We also expect this role to drive end to end thinking to make quality easy and contribute to finding the right solutions with both simplicity and compliance in mind.

Responsibilities
• Quality Assurance/advisor (as applicable) in the Content Control Process for Line of Business.
• Support QMS changes through coordination and collaboration with relevant stakeholders to ensure the changes are executed/implemented in compliance and fulfil the regulatory requirements.
• Keep deep knowledge of the Novo Nordisk QMS and relevant external requirements to coach and advice process owners or other stakeholders and set direction for SMEs.
• Associate suggestions for changes/improvements with business cases quantifying benefits and enabling effective communication.
• Stay updated on developments within cGxP and QA in general via participation in internal and external network.

Candidate Profile
• Graduate / post-graduate or Comparable degree in science or equivalent professional experience.
• Over-all 12+ years of work experience within pharma or healthcare industry.
• Experience within/from pharmaceutical quality management system e.g. GxP requirements and ISO13485.
• High level of experience in good documentation practices.
• Cross-organisational working experience.
• Basic cLEAN experience and relevant cLEAN tools.
• Participating in audits and inspections and compliance gaps analysis.
• Project Management experience is an added advantage.
• Excellent knowledge in core pharma GXP requirements (GLP, GMP and GCP) as well as internal requirements to keep systems/process in compliance.
• Impactful presentation and communication skills.
• Fluent English, written and spoken.

Additional Information
Experience : 12+ years
Qualification : Graduate / post-graduate or Comparable degree in science
Location : Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : R&D Quality GBS
End Date : 31st October 2023