Application Management Specialist

7 dagen geleden

Bilthoven, Gem. De Bilt; Provincie Utrecht, Nederland Bilthoven Biologicals Voltijd
ph3Application Manager QMS /h3 pAs an Application Manager QMS, you play a key role in optimizing and managing BBio’s QA platform within the pharmaceutical environment. You are responsible for the functional and technical management, further development, and ensuring compliance of the QA application as an important system in our organization. With your knowledge of application management preferably QA systems and again preferably within pharmaceutical regulations (GxP, GMP), you ensure that BBio’s processes are efficiently, safe, and future‑proof designed. The QMS software used by BBio is Veeva. /p h3Main tasks and responsibilities /h3 ul liTranslating business requirements into functional and technical solutions within Veeva. /li liAnalyzing incidents and performing necessary activities for and resulting from periodic reviews of the application, in accordance with GxP/GAMP5/ISO guidelines. /li liServing as a point of contact and sparring partner for internal stakeholders such as QA, Regulatory Affairs, and IT. /li /ul h3The Ideal Application Manager QMS /h3 ul liCompleted bachelor’s degree, preferably in Computer Science, Business IT Management, Pharmacy, Life Sciences, or equivalent. /li liStrong analytical skills and ability to translate business needs into IT solutions. /li liRelevant expertise in application management and change management. /li liPreferably relevant experience as an application specialist of a QMS, preferably in the pharmaceutical or life sciences sector. /li liExcellent communication skills in English and preferably also in Dutch. /li liA contract for 32 to 40 hours per week. /li liA declaration of conduct (VOG) is part of this application procedure. /With approximately 500 colleagues, BBio produces vaccines such as polio, diphtheria‑tetanus‑polio (DTP), and BCG.