Problem Solver with technical validation and GMP mind-set - Denmark
- Are you eager to contribute in delivering the best prefilled devices to the market?
- We are looking for a skilled process supporter with a high quality mind-set and GMP experience to join us in the Assembly support team placed in Diabetes Finished Products (DFP)
- Anticipate a key role where you will contribute to the implementation and documentation of efficiency based tasks related to the assembly processes and consolidate our compliance and product quality for our production and for the patients.
About the department
- You will be a part of a group of 12 dedicated and highly competent colleagues.
- Our primarily tasks is to handle both daily support to an intense production environment and tasks related to long term improvements of our production lines.
- Our field of responsibility for the assembly processes covers the validated state of the lines, the operational procedures to operate them, the expertise in the products and the continuous improvement of the production lines.
- As Process Supporter, your primary goal is to ensure that the production consistently delivers a high quality product in compliance with internal quality requirements and GMP maintaining validated state and sustaining “licence to operate”.
- First and foremost, you will have product and process support responsibility.
- You will handle Change Request actions (CR-actions) and actions related to Non-Conformities (NC’s) from the assembly process.
- You will be involved in updating vital process documentation.
- In collaboration with the product experts, you will assess the severity of potential defects and contribute to the elimination of the root causes.
- As we are working in a GMP environment, all activities have to be documented.
- In addition you will be responsible for identifying the biggest opportunities for improving performance and the compliance level of the existing production lines and ensure effective prioritization and execution of the initiatives.
- Depending on your profile you will be involved in different project activities that can span from small changes of existing production lines to major rebuilds and introduction of new production equipment. Furthermore you will be responsible for documentation of activities and document both current and future state of the equipment.
- As such you will be a major player in the continuous improvement of the product quality, process stability and efficiency in the Assembly department.
- You hold a Master’s degree in Mechanical Engineering, automation, machine commissioning, Production Engineering or similar combined with substantial practical experience in supporting automated manufacturing processes.
- Ideally you have a consistent experience from medical device production, validation and process documentation (URS, Risk assessment, CIL etc.).
- You have a proven track record within project coordination and have acquired solid GMP knowledge that enables you to understand what kind of impact changes can have on documentation and SOPs. It is important that you know LEAN and have a strong sense of quality.
- On a personal level, you are enthusiastic and committed. You are analytical and strong at systematic problem-solving.
- You also possess excellent cooperation and communication skills as your ability to interact with colleagues at various organisational levels is key in achieving success in this position.
- We are determined to continually improve our work and it is therefore important that you focus on seeing opportunities, creating good results and take on a proactive approach to ensure the achievement of these. Fluency in written and spoken Danish and English is expected.
Working with Us:
- We strive for excellence.
- As a world leader in diabetes care and a major player in haemostasis management, growth hormone therapy and hormone replacement therapy,
- We offer our employees opportunities for continuous growth.