ppAre you looking for an exciting opportunity to develop your skills in an international pharmaceutical company, with the aspiration of becoming the general leader in allergy treatment? Join ALK! We are leading global pharmaceutical company dedicated to improving lives for people living with allergies, and we are currently seeking for a Quality Assurance Specialist. /p h3Job Purpose: /h3 pThis position will contribute to ensure that performance of manufacturing, packaging operations and product quality are aligned with GMPs to ensure lasting customer satisfaction. This individual will demonstrate a high level of involvement in continuous improvement of the quality assurance philosophy and practice to ensure the right standards are implemented. /p h3Key Responsibilities: /h3 ul liPerform Quality Assurance activities associated with maintaining internal Quality Systems: Technical complaints, Change controls, CAPAS, Deviations, etc. /li liManagement of APQR reports: ul liAct as APQR lead coordinating inputs from the different Product Supply areas. /li liLead the APQR subsystem in the global forum. /li /ul /li liReview GMP technical and validation reports: ul liManufacturing and packaging processes. /li liComputer/Automated systems involved in testing, manufacturing or materials control. /li liCleaning Validation/Equipment cleaning procedures. /li liLaboratory and manufacturing equipment qualification. /li liFacilities and Utilities with product contact. /li liAnalytical methods validation. /li /ul /li liProvides on-site guidance in the preparation of procedures and working instructions. /li liDocumentation and Training system: ul liReinforce good documentation practices in both paper and electronic media. /li liSupport the execution of GMP-training program. /li /ul /li liSupport Quality Release activities:



ul liMaster batch records review and related documentation. /li liSite Master File update. /li /ul /li liAssists in providing resolution to GMP issues through identification of problem areas, refinement of systems, training and coaching of relevant personnel. /li liHelps support a permanent inspection readiness status. /li liProvide GMP quality expertise, advice and/or assistance across the organization as required. /li /ul h3Required Qualifications and Skills: /h3 ul liMinimum of 3 years’ experience in the pharmaceutical/biotech industry. /li liStudies related to Chemistry, Pharmacy, Biology or equivalent (university studies are valued). /li liFluent in English, both written and spoken. /li liKnowledge of regulations for sterile medicinal products and experience with technology transfer projects (mainly equipment qualification and process validation). /li liPrevious experience as a Qualified Person and proficiency with SAP would be desirable. /li liStrong interpersonal and leadership skills in dealing with a variety of cultures on non-routine matters in challenging situations, can deal organisational complexity and ambiguity. /li liFlexibility and a strong learning aptitude are required to support the different functions of the Quality Assurance department. /li /ul h3Why Join ALK? /h3 ul liProfessional Growth: Receive tailored training, participate in projects, and access unique learning opportunities within a leading international company. /li liCollaborative Culture: Work alongside passionate professionals, share knowledge, and make a meaningful difference in a culture of respect, diversity, and integrity. /li liInnovation and Excellence: Contribute with ideas and uphold the highest quality and regulatory standards. /li liCompetitive Benefits: Attractive salary, comprehensive benefits, and support for work-life balance. /li /ul /p #J-18808-Ljbffr

📌 QA Specialist (Madrid)
🏢 Alk-Abelló, A/S
📍 Madrid