Compliance Automation Specialist for Technical Services at in Copenhagen
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København
Technical Services
Are you our new specialist who has passion for GMP, qualification and documentation, and can you create an overview of the automatic systems used in our production?
You will be part of Technical services’ automation and calibration team and responsible for our production systems in CPH. The team is diverse and consists of 14 engaged colleagues, two of which you will be working closely with regarding computer system validation. In the team, we emphasize that there is always a helpful and relaxed tone. Xellia offers a flexible working environment with the possibility of home office days.
As CAS/CSV specialist, you are a key person in driving the process of creating overview and keeping the computer systems in a validated state. You will also assist the team and our project department in preparing URS, IQ and OQ protocols/reports in connection with projects and start our journey towards electronic validation with ReVerTo. This work will be done in cooperation with various system owners in the production departments and with the support of your own team. You will, therefore, have a large span of contacts with many different colleagues.
Taking your wishes and competences into account, you will have a big influence on your daily work life and the development of this position. We expect you to contribute with a systematic approach and to be open and attentive when retrieving information. You need to be outspoken and willing to take on a leading role in documenting the systems. It is important that you understand quality assurance and are passionate about doing things right. Operation skills and experience with handling of deviations, changes and CAPA in relation to GMP is preferred.
Your overall responsibility and primary tasks will be to prepare documentation describing computer systems that are part of the different production sections and covering many devices and multiple systems. There is a great desire and focus on ensuring the optimization potential of the systems and production and also in Technical Services itself. You will, therefore, contribute to succeed, both in the production environment and in your own department.
Examples of specific tasks in the position may include:
• collecting information about different systems and documenting it
• cooperating systematically with equipment owner to ensure valid data
• preparing qualification documentation
• delivering documentation for production
• making recommendations for improvement
• managing changes and deviations
• being gatekeeper on deliveries and deadlines
• producing relevant documentation
• writing SOP's and instructions
• coordinating cooperation with the production
• participating in inspections and audits.
We expect you to:
Have a background as an engineer, cand.scient or equivalent. You might come from a quality position and want to try to be on the other side of the table. Preferably with minimum three years of experience from a similar position. You master English, both written and spoken. The Danish language would be a plus, but it is not a must. You are structured, engaged and thrive at a high pace. We also expect you to be able to communicate with many organizational levels and be a positive partner for our production units. As everyday life is changing in relation to the rate of production, it is important that you thrive in a changing environment and can take responsibility, as well as show great flexibility and patience.
You are:
• focused
• detailed
• confidence-boosting
• full of drive and energy.
For further inquiries, you are very welcome to contact Team Leader David K. B. Møller Phone no. +45 20220394.
Xellia Pharmaceuticals is a specialty pharmaceutical company developing, manufacturing and commercializing anti-infective treatments against serious and often life-threatening bacterial and fungal infections. Headquartered in Copenhagen, Denmark, Xellia has a global footprint with R&D, manufacturing and commercial operations across Europe, Asia, the Middle East and North America. Xellia is wholly owned by Novo Holdings A/S and employs a dedicated team of over 1,800 people.
With over 115 years of experience, Xellia is a world-leading trusted supplier of several important established anti-infective drugs, comprising active pharmaceutical ingredients as well as injectable products. Continuing the Company’s evolution, Xellia is generating an innovative pipeline of value-added anti-infective medicines intended to enhance patient care, providing convenience and ease of use for healthcare professionals.
Together you can help us lead the fight against infections.
Further information about Xellia can be found at: www.xellia.com
Connect with us on LinkedIn
Information og data
Denne ledige stilling har jobtypen "Apoteker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i København
Jobbet er oprettet på vores service den 2.11.2021, men kan have været deaktiveret og genaktiveret igen.
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