Computer System Validation Specialist – Join us to explore compliance automationTechnical Services Are you well-versed in the art of computer system validation? And would you like a varied workday where you get to plan your own time? Step into a key specialist role which spans documentation of systems, validation and qualification of procedures as well as participation in key projects. “You will have a lot of influence on your daily tasks as well as your own development. If there is something you want to explore, all you need to do is speak up,” Team Leader Iman Al-Hilali explains. Join our compliance teamAt our headquarters in Copenhagen, you will become part of our Technical Services’ Automation department, which is responsible for our CPH production systems. Here, you will join our compliance team, which consists of three close colleagues who will welcome you to a helpful and relaxed environment where you have the option of working from home two days a week. Moreover, we are a growing team, so you will have a lot of opportunity to impact how we collaborate and operate in the future. “Also, we have a lot of freedom to structure our own time – and participating in projects, you will be in contact with many different colleagues and quickly discover our organisational team spirit,” Iman goes on to say. Spearhead compliance and innovation in computer systemsAs our new Computer System Validation Specialist, you will be stepping into a key position where you will be responsible for creating an overview of our computer systems and keeping them in a validated state. You will ensure our data integrity, participate in projects as compliance lead – Usually, you will be assigned to two at a time – and assist in preparing URS, IQ and OQ protocols/reports. Doing this, you will be collaborating with various system owners from our production departments – and with colleagues from your team, of course. More specifically, you will: take charge of compliance in automation projects across our CPH site execute and oversee qualification tasks, providing crucial support to automation projects provide strategic input, contributing to shaping the direction and strategy for computerized systems’ qualification collaborate closely with equipment owners to ensure the integrity of valid data conduct periodic reviews of validated systems to ensure alignment with regulatory requirements and business needs handle documentation updates, including SOPs and instructions, and participate in inspections and audits. “The projects will take up a lot of your time, but there are also a lot of ad hoc tasks for you to season your time with – so truly no two days are alike, and I guarantee you will not be bored,” Iman concludes. GMP experience and an eye for quality and computerized systemsYou know how to provide effective communication across different organizational levels, and you are a positive collaborator ready to interact with our production units. You also know how to navigate a constantly changing environment, taking responsibility and demonstrating patience. With a systematic approach and an open and inquisitive mindset when gathering information, you are ready to set the direction for our computer system validation. Finally, we imagine that you: have experience from a similar role or a quality-related position hold an engineering degree, a Master of Science or equivalent have knowledge of automation, data or production have a deep understanding of quality assurance have experience with cGMP and the associated technical documentation are fluent in English – Danish language skills are not a requirement, but you need to live in Denmark. Additional information and how to applyPlease submit your CV and cover letter as soon as possible and no later than 6 October 2023. If you have any questions regarding the position, please reach out to Team Leader Iman Al-Hilali on +45 41 93 37 53. 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