IT QA specialist - Quality Systems
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Quality
We are looking for an experienced Quality System Specialist with an IT background to join our Global Quality Systems and Training team (GQST). You will act as global business process owner for some of our key quality systems and processes with responsibilities for, but not limited to, systems qualification and validation. 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 global business process owner for some of our processes, including but not limited to: data integrity, computerized system validation, system periodic reviews and risk assessments.
In this role, you will be expected to:
- maintain global computerized system validations
- support and approve computerized system qualification runs
- support sites on locally applied computerized system validation
- 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 12 highly specialized individuals divided into four teams; one of which is Global Quality Systems and Training (GQST). We are a global team with colleagues in Budapest, Copenhagen, Oslo, and Cleveland. You will be the only IT QA resource working locally to support the site in Copenhagen, and it is important that you thrive in such an environment. You will always have strong backup and support from your global team colleagues.
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 shares 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?
Ideally you have a good understanding of pharmaceutical quality management processes with relevant work experience and also good knowledge of computerized system validation and Good Automated Manufacturing Practices (GAMP). Knowledge of HP ALM application is an advantage.
We are also open for other industry-related experience, where quality and validations of IT systems are highly prioritized.
You must have a relevant academic degree with a minimum of five-six years of relevant experience. Also, you must be fluent in English, both in verbal and written communication.
Key Competencies
- You must have a pragmatic mindset and effective communication skills towards a diverse range of stakeholders 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
- You should have strong influencing skills to help move decision-making into action.
What will we offer you?
At Xellia, we focus on having a great working environment, job satisfaction, and good employee benefits. You will get a challenging job in an international and dynamic company, where you can look forward to collaborating closely with highly qualified colleagues and a wide range of contacts. You will get a varied and independent job with great responsibility, a good working climate, and with room to have a fun working day. We also offer a competitive salary package that matches your qualifications.
Contact and apply
Please submit your CV and cover letter as soon as possible and no later than 16 October 2022. If you have any questions regarding the position, you are welcome to contact GQST Manager Balázs Brunner on phone +36 30 3417145.
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 "Produktspecialist", og befinder sig i kategorien "Kommunikation, marketing, salg".
Arbejdsstedet er beliggende i København
Jobbet er oprettet på vores service den 9.3.2022, men kan have været deaktiveret og genaktiveret igen.
- Produktspecialist
- København
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