QA Engineer
- Quality
- Denmark - Hillerød
Would you like to work in an international environment and be responsible for the quality assurance of the components for the future prefilled insulin pen and for approving training material for Device Manufacturing Sourcing (DMS) production? Are you ready to take high impact decisions regarding the right level of quality to ensure patient safety? Then you might be the person we are looking for.
About the department
Due to a production ramp-up in DMS, we are looking for a dedicated person who will be part of the Manufacturing Quality Assurance team of 8 QA engineers. The Manufacturing QA team is responsible for the quality assurance of all components produced internally in Novo Nordisk and delivered for production of medical devices worldwide.
The job
As a QA professional you will be responsible for ensuring and developing quality and compliance of the current production in DMS and our quality systems with Novo Nordisk regulations, legal requirements, GMP, and ISO standards.
This covers handling of documentation – including review of batch documentation, handling of deviations and writing and approving change requests as well as approving non-conformity investigations. You will negotiate with colleagues to get continuous improvements of products and processes and participate in investigation of root causes to non-conformities and customer complaints. You will also promote sharing of better practice and improve compliance projects within DMS.
Additionally, you will be responsible of the daily QA approving of training material for operators in DMS, managing change requests for job instructions within DMS as well as releasing the final documents and ensure document control. To achieve that, you will cooperate closely with operators and training partners to ensure correct updates of Operation Procedures. This will also involve
In your daily work, you will interact with several departments such as Process Support, Logistics & Quality Control, Mould and Pre-assembly production, and your success will depend on your ability to be a role model with regards to collaboration and communication with all types of colleagues and business partners.
Quality Mind-set and winning culture are incorporated concepts of our daily work. We offer you a position in an international company with many exiting challenges giving you the possibility for individual development.
Qualifications
First and foremost you have an excellent quality mind-set, good communicational skills and you can place the importance of compliance on the agenda in a positive and constructive way.
You hold an academic degree. Preferably your academic background is topped with
3-5 years of experience with quality assurance within the pharmaceutical industry or from a Production company. It is an advantage if You have experience with ISO13485, GMP, and Lean or process insight in injection moulding and assembly production
Your language skills cover proficiency in both Danish and English,
As a person, you are known for a high commitment to finding constructive solutions as well as taking responsibility for your assignments.
You enjoy the mixture of routine tasks and more challenging tasks, and you are flexible to changes in workflow. Additionally, you work independently and you make decisions regarding quality tasks ensuring the right balance between quality demands, authority demands and business needs. At the same time, you perform well in a team-oriented environment.
At Novo Nordisk, 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
Contact
For further information, please call Lotte Nielsen + 45 3079 4276.
Deadline
27 January 2014
- Quality
- Denmark - Hillerød
Would you like to work in an international environment and be responsible for the quality assurance of the components for the future prefilled insulin pen and for approving training material for Device Manufacturing Sourcing (DMS) production? Are you ready to take high impact decisions regarding the right level of quality to ensure patient safety? Then you might be the person we are looking for.
About the department
Due to a production ramp-up in DMS, we are looking for a dedicated person who will be part of the Manufacturing Quality Assurance team of 8 QA engineers. The Manufacturing QA team is responsible for the quality assurance of all components produced internally in Novo Nordisk and delivered for production of medical devices worldwide.
The job
As a QA professional you will be responsible for ensuring and developing quality and compliance of the current production in DMS and our quality systems with Novo Nordisk regulations, legal requirements, GMP, and ISO standards.
This covers handling of documentation – including review of batch documentation, handling of deviations and writing and approving change requests as well as approving non-conformity investigations. You will negotiate with colleagues to get continuous improvements of products and processes and participate in investigation of root causes to non-conformities and customer complaints. You will also promote sharing of better practice and improve compliance projects within DMS.
Additionally, you will be responsible of the daily QA approving of training material for operators in DMS, managing change requests for job instructions within DMS as well as releasing the final documents and ensure document control. To achieve that, you will cooperate closely with operators and training partners to ensure correct updates of Operation Procedures. This will also involve
In your daily work, you will interact with several departments such as Process Support, Logistics & Quality Control, Mould and Pre-assembly production, and your success will depend on your ability to be a role model with regards to collaboration and communication with all types of colleagues and business partners.
Quality Mind-set and winning culture are incorporated concepts of our daily work. We offer you a position in an international company with many exiting challenges giving you the possibility for individual development.
Qualifications
First and foremost you have an excellent quality mind-set, good communicational skills and you can place the importance of compliance on the agenda in a positive and constructive way.
You hold an academic degree. Preferably your academic background is topped with
3-5 years of experience with quality assurance within the pharmaceutical industry or from a Production company. It is an advantage if You have experience with ISO13485, GMP, and Lean or process insight in injection moulding and assembly production
Your language skills cover proficiency in both Danish and English,
As a person, you are known for a high commitment to finding constructive solutions as well as taking responsibility for your assignments.
You enjoy the mixture of routine tasks and more challenging tasks, and you are flexible to changes in workflow. Additionally, you work independently and you make decisions regarding quality tasks ensuring the right balance between quality demands, authority demands and business needs. At the same time, you perform well in a team-oriented environment.
At Novo Nordisk, 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
Contact
For further information, please call Lotte Nielsen + 45 3079 4276.
Deadline
27 January 2014