GxP System Specialist

Job description

Are you experienced with Application Lifecycle Management system and GxP automation? Do you thrive in a global environment and want to advance your career withing life sciences? If so, we invite you to keep reading. Your role as GxP System Specialist: You will join the ALK Global Business IT Business Application Systems (BAS) department as process owner for Application Lifecycle Management system and GxP automation. In ALK, we use OpenText ALM for Application Lifecycle Management and OpenText UFT for GxP automation. In this role, you will combine strong process ownership with hands-on system and tooling expertise to drive improvement and innovation in a GxP enviroment, your Key Responsibilities include: Own and continuously improve ALK's Application Lifecycle Management system (OpenText ALM), ensuring it remains compliant, efficient, and fit for purpose as regulatory and business needs evolve. Support computer system validation (CSV) activities for ALK’s automation and test-automation solutions (OpenText UFT) that fall within GxP scope, applying a risk-based approach throughout. Drive the creation and maintenance of QMS-related SOPs and Work Instructions for OpenText ALM and OpenText UFT, keeping documentation current with regulatory expectations. Proactively identify and manage improvement opportunities across Global IT systems, including expanding automated and computer-aided testing to increase coverage and efficiency. It is preferred that the candidate has solid knowledge of compliance, so the candidate can also take further responsibilities include: Lead the GxP compliance framework for projects and releases across ALK's Veeva Vault portfolio, coordinating impact assessments and validation activities. Support the handling of Deviations, CAPAs, and Change Controls for systems owned by our department, ensuring timely and well-documented resolution. Assist in representing Business Application Systems during internal and external inspections and audits, preparing and presenting validation and automation evidence. Your qualifications to enable you to succeed in this role: IT Qualifications: Bachelor’s or master’s degree in computer science, Engineering, or a related field. 3+ years of professional experience within pharmaceutical or other GxP-regulated industries. 3+ years of hands-on experience with Computer System Validation (CSV) and GxP compliance requirements. Solid, hands-on experience with ALM (Application Lifecycle Management) is required. Experience with Veeva Vault QualityDocs and Veeva Vault RIM is an advantage. General Qualifications: Quick learner with a genuine interest in new applications and technologies. Innovative mindsets paired with a pragmatic, can-do attitude. A structured, quality-first mindset is essential, with the ability to follow and document processes in line with ALK's quality standards. Proficiency in both written and spoken English. Proven ability to collaborate effectively and thrive in an international environment, with colleagues located in Hørsholm, Madrid, and Krakow. Flexibility to travel up to 10 days per year, primarily within Europe. World Leader in Allergy: ALK’s goal is to become the global leader in allergy care by helping many people live better lives through prevention, diagnosis, and treatment options. In Global IT, we play a key role in this mission by supporting the organization with cutting-edge IT tools and technologies, and by providing world-class support to our colleagues around the world. Global IT at ALK: Global IT at ALK is a diverse, international team of approximately 140 employees, with key hubs in Hørsholm, Madrid, and Krakow, along with IT staff at production sites and regional sales hubs in Germany, France, and North America. ALK predominantly manages its IT expertise in-house, offering you the chance to collaborate with talented colleagues from around the world. We believe that achieving outstanding results and delivering exceptional IT services go hand in hand fostering development and learning opportunities. Our employees are encouraged to connect and support each other daily. You will join an IT organization that values competence and substance over style and presentation, and that thrives on collaborative, iterative teamwork. We look forward to hearing from you! Are you experienced with Application Lifecycle Management system and GxP automation? Do you thrive in a global environment and want to advance your career withing life sciences? If so, we invite you to keep reading.