- Provide support and work as sparring partner on quality matters to ensure compliance with existing and new requirements.
- Identify trends and possibilities for improvements across the department, that can reduce complexity and build quality and robustness into the processes.
- Prepare the department for internal audits and inspections.
- Plan and host training in GMP and QMS.
- Prepare trend reports, quality oversight tools, Quality Management Review etc.
- You have at least 3 years of experience with GMP from relevant position in the pharmaceutical or other highly regulated industry.
- You hold master's degree within chemistry, life sciences or another relevant field.
- You have experience with some of the following processes and preferably with most of them: deviation handling, change requests, qualification and validation, environmental monitoring and quality control - in order to be able to provide support on the topics.
- You are curious and able to see opportunities for improvement. Independence is a prerequisite, as well as the ability to collaborate with various groups of employees with different backgrounds.
- You are fluent in English.
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Quality Coordinator - Kalundborg, Danmark - Novo Nordisk A/S
Beskrivelse
Are you passionate about ensuring compliance and driving continuous improvement in quality processes? Do you thrive in a dynamic environment where you can collaborate with cross-functional teams and support production? Do you enjoy analysing data to spot trends, and does inspection and audits excite you? If yes, we can offer you an exciting position, where your quality mindset and interest in being close to production will be extremely valuable for us as a company reaching our ambitious goals. Apply today for a life-changing career
The position
It is an exciting and challenging position with a wide variety of quality related tasks and many different stakeholders.
Some of the key responsibilities are:
As a Quality Coordinator you will be a part of the M1 quality coordinator group who are working closely together. You will have the possibility to be a member of the cross functional process groups, setting direction for quality management across API. This requires good communication skills and close collaboration with other CVP areas.
Furthermore, in this role you will have a central role during inspections, working with regulatory officials and coordinating across different groups involved. Doing an excellent job and proposing innovative improvements will allow you to demonstrate positive outcomes and impact decisions made by the management team. This position provides the chance to build a wide range of skills by being involved in various quality management areas.
Qualifications
To succeed in this position, we imagine:
The position requires a high-quality mindset and the ability to act as a role model in setting the direction about Quality and Compliance issues. Furthermore, it is essential that you are curious to understand and gain energy by going on the shop floor and interact with production.
About the department
You will join the M1 Utility & Solvents department that provides support to Active Pharmaceutical Ingredient's (API's) production departments within the areas. We consist of ~80 employees organised in five teams. In the department, we are responsible for daily operations of raw materials, solvents and utilities from the fermentation to the finished API, documentation, troubleshooting and process optimisation and projects.
As quality coordinator you will be a part of the department's management team and refer to the department manager.
We share an informal tone and ambitions to be the best at what we do – and we are good at helping each other and share both challenges and victories alike.