PbQA Specialist – Qualification Aseptic Operations | Pharmaceutical Manufacturing /b /ppbr/ppbLocation: /b Madrid, Spain - onsite /ppbLanguages: /b Spanish (fluent), English (advanced) /ppbr/ppbAre you an expert in qualification and aseptic operations? /b /ppWe are seeking a pro-active QA Specialist to ensure the highest standards of compliance, product integrity, and operational excellence at our new state-of-the-art facility. /ppbr/ppbResponsibilities: /b /pulliReview and approve qualification/validation documents for equipment, utilities, HVAC, water, and production areas. /liliMaintain compliance with EU Annex 1, aseptic techniques, cleanroom behavior, and contamination control best practices. /liliProvide QA oversight for commissioning, qualification, and validation (CQV) activities. /liliEvaluate deviations, CAPAs, and change controls—supporting thorough investigations and root-cause analysis. /liliParticipate in GMP walkthroughs, on-site quality checks, and aseptic observations. /liliAct as a key QA partner for engineering, production, microbiology, and validation teams—driving qualification excellence. /liliChampion data integrity and continuous improvement initiatives for sterile manufacturing. /liliDeliver training and guidance on aseptic behavior and EU Annex 1 expectations. /li /ulpbr/ppbRequirements: /b /pulliBachelor’s or higher in Pharmacy, Life Sciences, Engineering, or a related field. /lili3+ years’ QA experience in GMP pharma, with strong background in qualification/validation and sterile environments. /liliDeep understanding of EU Annex 1 and aseptic operations. /liliExcellent communicator, detail-oriented, and fluent in Spanish and English. /li /ulpbr/ppJoin us and make your mark by advancing quality and safety in pharmaceuticals! /p