Quality System IT Specialist
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Quality
We are looking for an experienced Quality System IT Specialist to join our Global Quality Systems and Training team (GQST). Your role will be as a global business process owner for some of our key quality processes. The position will be based in Copenhagen; however, some travel should be expected.
What will you do?
As our new Quality System Specialist, you will be a global business process owner for some of our processes, including but not limited to data integrity, computer system validation, Good Automated Manufacturing Practices (GAMP), and risk management.
In this role, you will be expected to:
- deliver process improvement activities, update procedures, and oversee the implementation
- design, create, and plan delivery of training across multiple sites
- identify, define, and implement appropriate key performance indicators
- collect the data needed to measure and manage process performance
- establish and/or lead a process or sub-process core team with guidance
- understand how relevant IT systems support/enable the business process
- Partner with our global IT function and advise on GxP compliance
You will become part of an experienced team
The Global Quality Systems, Audits and Compliance (GQSAC) department consists of 16 highly specialized individuals divided into four teams; one of which is the Global Quality Systems and Training (GQST). We are a global team with colleagues in both Budapest, Copenhagen, Oslo, Raleigh, and Zagreb.
GQST has a central role in establishing an effective and efficient Quality Management System (QMS), which sets the direction and guides all Xellians to work in compliance with the regulations that govern our industry. As a global team, we ensure that the quality processes, when updated, will continue to provide value and work as intended across all sites and countries. As such, GQST is considered a key business partner across functions.
Quality is in our DNA
Quality is embedded in every aspect of our business and the way we support our internal and external customers. You will become a part of a team that share the passion for Quality Management Systems, Process Management and its IT Systems. As process owner, you will have a network of specialists across our sites globally with whom you will collaborate on continuous improvement initiatives. For processes supported by IT systems, you will also work in close collaboration with the system developers located in various locations around the world.
What experience do you need?
You must have a relevant academic degree with a minimum of 5-6 years of experience. Also, you must be fluent in English, both in terms of verbal and written communication. You should have a good understanding of pharmaceutical quality management processes with relevant work experience and knowledge of ISO 9001.
Key Competencies
- You must have a pragmatic mindset and effective communication skills towards a diverse range of stakeholders in order to promote quality mindset and facilitate change
- You must be an open-minded person who considers multiple points of view
- You should enjoy challenges and the rewards of being of service to others
- You must be able to build strong relationships with our business partners
What will we offer you?
At Xellia, we focus on having a great working environment, job satisfaction, and good conditions. You get a challenging job in an international and dynamic company, where you can look forward to a close collaboration with highly qualified colleagues and a wide range of contacts. You will get a varied and independent job with great responsibility and a good working climate with room to have a fun working day. We also offer a competitive salary package that matches your qualifications.
Additional information and how to apply
Please submit your CV and cover letter as soon as possible and no later than 20. November 2020. If you have any questions regarding the position, please contact Senior Director Global Quality Systems Audits and Compliance, Peter Albrechtsen on +45 31 92 84 24.
Xellia Pharmaceuticals is owned by Novo Holding A/S and is a specialty pharmaceutical company leading in the development, manufacture and supply of anti-infective treatments. Headquartered in Copenhagen, Denmark, Xellia has global facilities in Europe, North America, and Asia, currently employing over 1700 people. With over 100 years of industry experience in developing last resort treatments for infectious diseases, Xellia is focused on the supply of products which not only save lives, but also improve and enhance patients’ quality of life. Together with us, you can help lead the fight against bacterial infections.
Read more about Xellia Pharmaceuticals here
Information og data
Denne ledige stilling har jobtypen "Frontendudvikler", og befinder sig i kategorien "Informationsteknologi".
Arbejdsstedet er beliggende i København
Jobbet er oprettet på vores service den 29.10.2020, men kan have været deaktiveret og genaktiveret igen.
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