Senior QMS Professional
Found in: beBee jobs DK - 1 week ago
You will:
Implement change requests, e.
G. For new/updated product specifications. Handle quality related tasks, such as SOP reviews/updates. Take part in CMO collaborations incl. Site audits/visits and document flow management. Collaborate with colleagues from other parts of CMC and manufacturing development, quality assurance and regulatory affairs. Take part in/lead standardising and optimising above mentioned tasks/processes. Furthermore, and depending on your qualifications and motivation, you are likely to be involved in regulatory documentation processes.
Here assignments could include:
write and review regulatory submission documents such as CTA (Clinical Trial Applications) and marketing applications related to the analytical field.
take part in the process of answering questions from health authorities across the globe related to our submissions. take part in giving content to the way we write our regulatory documents based on continuous learnings and feedback.To succeed in this role, you will take ownership and have a proactive approach and close cooperation with colleagues in the Project Office and analytical departments, ensure that our setup and documentation is in order and that required product quality and compliance is achieved.
Qualifications We are currently looking for a colleague with experience from a quality related position, ideally combined with analytical development, as well as a Master's degree within Pharmacy, Chemistry, Engineering, or a similar field.
To be successful in this role, the following qualifications are relevant:Strong knowledge and experience in quality management systems from pharmaceutical industry. Experience in writing and driving change request with many stakeholders. Familiarity with auditing, monitoring, and determining the quality of processes. Excellent attention to detail and ability to identify recurring problems. Good communication and collaboration skills. Experience with documents such as Justification of specification and product specifications. You have a structured and detail-oriented approach to everything you do.
You take pride in delivering high quality documents and to do so you build and create a network to improve your knowledge and skills.
On a personal note, you are open-minded, enjoy sparring and great colleagueship.The department As part of Novo Nordisk PSQIT organisation, Chemistry, Manufacturing and Control (CMC) Development & Scaling makes a real difference for patients with chronic diseases across the world.
We develop, manufacture and distribute drug candidates for clinical trials and have a strong culture with a "can do" mind-set.
Your new department, CMC Drug Product Development- Project Office, consists of 50 employees located in Måløv.
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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