QA Professional
- Quality
- Denmark - Bagsværd
If you want to make a difference for thousands of people daily by ensuring a high level of quality of the products of Novo Nordisk, then you might be the QA Professional we are looking for. CLM QA is responsible for quality assurance and quality support for production activities worldwide. This can be in the form of licence and contract manufacturing arrangements or via local production set up involving the Novo Nordisk affiliates.
CLM QA is part of Contract and Local Manufacturing (CLM), which is a unit in Devices & Supply Chain Management in Product Supply, Novo Nordisk A/S.
About the department
CLM QA is a dynamic department with 18 people divided into 2 teams. The open position is in the team CLM QA aseptic & projects that are responsible for implementing new CMOs and quality assurance of existing CMOs working primarily with aseptic production. The department is characterised by a high level of professionalism, flexibility and helpfulness. Since our manufacturers are located worldwide you will have the opportunity to travel and work with different cultures. You can expect 4-6 travels of varying length per year.
The job
As a QA professional you will be responsible for quality assurance of one or more of our CMOs. You will have to offer QA support and GMP guidance to our partners and do final release/authorisation of the finished products and ensuring that our products are manufactured according to cGMP and our marketing authorisations.
You will have numerous encounters daily with both internal and external business partners and you should expect a high level of complexity in your daily tasks. You will solve a wide variety of tasks and have a great opportunity to be challenged every day.
The daily QA activities are typically carried out by the contract and licence manufacturers themselves, but handling of documentation from contract manufacturers including e.g. review of batch documentation, handling of deviations and change control cases, and participation in audits is a part of the job.
If you are looking for a job, which can foster the development of your professional and personal competences, this may be your opportunity. Given that the majority of our contract manufacturers are located abroad, you will be exposed to different cultures and be expected to have a high degree of cross-cultural awareness.
Qualifications
You must hold a master degree which meets DHMA’s demands to qualified persons in the pharmaceutical industry (i.e. a university degree within pharmacy, medical science, veterinary science, chemistry, biology or pharmaceutical chemistry and technology).
Since CLM QA covers many activities related to finished products manufacturing, experience with aseptic production and/or quality assurance of either sterile/aseptic manufactured products or packaging processes will be considered an asset.
As a person, you take responsibility for your assignments, and your high engagement leads you to find constructive solutions. You work independently and make decisions regarding quality tasks, and always ensure the right balance between quality demands, authority demands and business needs.
You are robust, keep your focus in a hectic environment, and have strong communication and interpersonal skills. You have clout and thrive when delivering results.
Quality mindset is an integrated part of your personality and you have a broad network and preferable knowledge of Novo Nordisk production activities. You write and speak English fluently as a large part of the daily work is communication with our external business partners.
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 contact Anja Gøtø on +45 3075 4458 or Laila Agertoft +45 3075 4225.
Deadline
12 January 2014.
- Quality
- Denmark - Bagsværd
If you want to make a difference for thousands of people daily by ensuring a high level of quality of the products of Novo Nordisk, then you might be the QA Professional we are looking for. CLM QA is responsible for quality assurance and quality support for production activities worldwide. This can be in the form of licence and contract manufacturing arrangements or via local production set up involving the Novo Nordisk affiliates.
CLM QA is part of Contract and Local Manufacturing (CLM), which is a unit in Devices & Supply Chain Management in Product Supply, Novo Nordisk A/S.
About the department
CLM QA is a dynamic department with 18 people divided into 2 teams. The open position is in the team CLM QA aseptic & projects that are responsible for implementing new CMOs and quality assurance of existing CMOs working primarily with aseptic production. The department is characterised by a high level of professionalism, flexibility and helpfulness. Since our manufacturers are located worldwide you will have the opportunity to travel and work with different cultures. You can expect 4-6 travels of varying length per year.
The job
As a QA professional you will be responsible for quality assurance of one or more of our CMOs. You will have to offer QA support and GMP guidance to our partners and do final release/authorisation of the finished products and ensuring that our products are manufactured according to cGMP and our marketing authorisations.
You will have numerous encounters daily with both internal and external business partners and you should expect a high level of complexity in your daily tasks. You will solve a wide variety of tasks and have a great opportunity to be challenged every day.
The daily QA activities are typically carried out by the contract and licence manufacturers themselves, but handling of documentation from contract manufacturers including e.g. review of batch documentation, handling of deviations and change control cases, and participation in audits is a part of the job.
If you are looking for a job, which can foster the development of your professional and personal competences, this may be your opportunity. Given that the majority of our contract manufacturers are located abroad, you will be exposed to different cultures and be expected to have a high degree of cross-cultural awareness.
Qualifications
You must hold a master degree which meets DHMA’s demands to qualified persons in the pharmaceutical industry (i.e. a university degree within pharmacy, medical science, veterinary science, chemistry, biology or pharmaceutical chemistry and technology).
Since CLM QA covers many activities related to finished products manufacturing, experience with aseptic production and/or quality assurance of either sterile/aseptic manufactured products or packaging processes will be considered an asset.
As a person, you take responsibility for your assignments, and your high engagement leads you to find constructive solutions. You work independently and make decisions regarding quality tasks, and always ensure the right balance between quality demands, authority demands and business needs.
You are robust, keep your focus in a hectic environment, and have strong communication and interpersonal skills. You have clout and thrive when delivering results.
Quality mindset is an integrated part of your personality and you have a broad network and preferable knowledge of Novo Nordisk production activities. You write and speak English fluently as a large part of the daily work is communication with our external business partners.
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 contact Anja Gøtø on +45 3075 4458 or Laila Agertoft +45 3075 4225.
Deadline
12 January 2014.