Senior QA Professional with CMO expertise
4 weeks ago
The job
As a Senior QP delegate, you will be responsible for delivering best-in-class quality assurance of our new manufacturing processes and drug product for clinical trials. In your daily work you will challenge and approve documents in connection with development, manufacture, stability, and status assignment of clinical batches produced in CMC and PS. You will primarily be working in Måløv and must expect traveling days as we are outsourcing more and more of our clinical batch productions to different international Contract Manufacturing Organisations (CMO). You will participate in pre-assessments of new CMO´s, act as Subject Matter Expert at audits, occasionally conduct quality oversight and review batches at the CMOs. Qualifications You hold a MSc in Pharmacy, Engineering, Biology, Chemistry or similar and fulfil the requirements from the Danish Health Authorities to become QP delegate. You have several years of experience within GMP and quality assurance - preferably within batch release/status assignment. Experience with qualification activities in aseptic production is a great advantage. The ideal candidate has been working with outsourcing/CMO collaboration and brings solid knowledge into the position. The most important asset that you can bring to succeed in this job is a well-developed understanding of quality and a natural urge to handle quality issues at the right level, make decisions and follow-up on quality related problems. You have a profound understanding of the important aspects of regulations, requirements and guidelines for pharmaceutical development and production and hence can navigate without adding complexity. You are a self-driven and independent person with a high sense of responsibility and initiative who can prioritise your many different tasks. You thrive in a dynamic environment, where teamwork is on the top of the agenda, and like working with many different stakeholders – internally and externally. You have very good communication as well as collaboration skills and must speak and write English fluently. We also expect that you speak, read, and understand Danish at a high professional level. About the department You will become part of a department consisting of three teams where we currently are more than 35 dedicated colleagues. Our main purpose is to safeguard patient safety and ensure product quality and compliance. As part of Novo Nordisk Quality, we support the business and strive for simplicity every single day, to ensure Novo Nordisk’s critical delivery of medicines to patients in our clinical trials. Working at Novo Nordisk At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales – we’re all working to move the needle on patient care.-
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