Senior IT QA Professional/Specialist in the R&D area
- Research & Development
- Denmark - Søborg
Would you enjoy the high activity of Quality Assurance (QA) within broad spectra of IT quality? Do you have an IT background? Do you have a balanced robust personality? Can you with an open-minded attitude argue for adhering to quality and authority requirements – internally as well as externally?
If you find challenges like these exciting and inspiring, you may be our new ITQS Professional, Specialist.
About the department
R&D QA in R&D Quality, Novo Nordisk A/S, is responsible for quality assurance and provides quality and compliance support in Research & Development (R&D). The department consists of three integrated teams: IT Quality Support team, RA team and the QMS team. The vacancy is placed in the IT Quality Support team.
The team focuses on IT quality assurance and support in R&D; mainly Global Development and Regulatory Affairs, but also Biopharmaceuticals Research Unit and Diabetes Research Unit. The main responsibility of the department however is QA approval and Novo Nordisk Quality Management System (QMS) in general.
The Job
As Senior ITQS Professional/Specialist you will be responsible for quality assurance of one or more IT systems in R&D and provide quality and compliance support to stakeholders in R&D. You will conduct IT quality training, review of procedures and support at audits and inspections.
The IT Quality Support team works closely together with other parts of R&D QA and R&D Quality on GCP and GMP requirements, QMS requirements, input to global IT Procedures and IT quality issues in general. Likewise R&D QA and the IT Quality Support team have a close cooperation with other relevant parts of Novo Nordisk. Our stakeholders’ primary regulatory requirements are GCP, GMP, ISO9001 as defined in Novo Nordisk QMS.
You will cooperate with many other professionals and working cultures globally, which is why personal flexibility is a ‘must’. Together with R&D QA, IT Quality Support team and stakeholders you will continuously improve the quality mind-set within Novo Nordisk.
The job requires independence and the ability to work with quality IT processes in a holistic way which is the key to our success.
Qualifications
You hold a relevant scientific academic degree, e.g. within Computer Science, Software Engineering or equivalent and are fluent in written and spoken English. The position requires significant insight into key IT processes, e.g. software engineering, quality management, change management, configuration management, risk assessment, testing, auditing etc., and experience with teaching and project management would be preferred . It is an advantage if you have experience with regulatory requirements within the GCP or GMP area or have worked as QA or in a quality function in the pharmaceutical industry.
You have a pragmatic approach to problem solving and strong interpersonal skills. You are detail-oriented with a strong quality mind-set and a team player prepared to work in a dynamic international environment with tight deadlines while maintaining a good sense of humour. We also expect you to be active in improving our systems.
If you have some of the above job qualifications, please let us know what you can contribute to R&D QA ITQS team.
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 Anders Ravn Sørensen at +45 3075 4724 or Lone Bau at +45 3075 7225.
Deadline
19 January 2014.
- Research & Development
- Denmark - Søborg
Would you enjoy the high activity of Quality Assurance (QA) within broad spectra of IT quality? Do you have an IT background? Do you have a balanced robust personality? Can you with an open-minded attitude argue for adhering to quality and authority requirements – internally as well as externally?
If you find challenges like these exciting and inspiring, you may be our new ITQS Professional, Specialist.
About the department
R&D QA in R&D Quality, Novo Nordisk A/S, is responsible for quality assurance and provides quality and compliance support in Research & Development (R&D). The department consists of three integrated teams: IT Quality Support team, RA team and the QMS team. The vacancy is placed in the IT Quality Support team.
The team focuses on IT quality assurance and support in R&D; mainly Global Development and Regulatory Affairs, but also Biopharmaceuticals Research Unit and Diabetes Research Unit. The main responsibility of the department however is QA approval and Novo Nordisk Quality Management System (QMS) in general.
The Job
As Senior ITQS Professional/Specialist you will be responsible for quality assurance of one or more IT systems in R&D and provide quality and compliance support to stakeholders in R&D. You will conduct IT quality training, review of procedures and support at audits and inspections.
The IT Quality Support team works closely together with other parts of R&D QA and R&D Quality on GCP and GMP requirements, QMS requirements, input to global IT Procedures and IT quality issues in general. Likewise R&D QA and the IT Quality Support team have a close cooperation with other relevant parts of Novo Nordisk. Our stakeholders’ primary regulatory requirements are GCP, GMP, ISO9001 as defined in Novo Nordisk QMS.
You will cooperate with many other professionals and working cultures globally, which is why personal flexibility is a ‘must’. Together with R&D QA, IT Quality Support team and stakeholders you will continuously improve the quality mind-set within Novo Nordisk.
The job requires independence and the ability to work with quality IT processes in a holistic way which is the key to our success.
Qualifications
You hold a relevant scientific academic degree, e.g. within Computer Science, Software Engineering or equivalent and are fluent in written and spoken English. The position requires significant insight into key IT processes, e.g. software engineering, quality management, change management, configuration management, risk assessment, testing, auditing etc., and experience with teaching and project management would be preferred . It is an advantage if you have experience with regulatory requirements within the GCP or GMP area or have worked as QA or in a quality function in the pharmaceutical industry.
You have a pragmatic approach to problem solving and strong interpersonal skills. You are detail-oriented with a strong quality mind-set and a team player prepared to work in a dynamic international environment with tight deadlines while maintaining a good sense of humour. We also expect you to be active in improving our systems.
If you have some of the above job qualifications, please let us know what you can contribute to R&D QA ITQS team.
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 Anders Ravn Sørensen at +45 3075 4724 or Lone Bau at +45 3075 7225.
Deadline
19 January 2014.