Descripción de la oferta
QA Specialist – Qualification & Aseptic Operations | Pharmaceutical Manufacturing Location: Madrid, Spain - onsite Languages: Spanish (fluent), English (advanced) Are you an expert in qualification and aseptic operations? We 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. Responsibilities: Review and approve qualification/validation documents for equipment, utilities, HVAC, water, and production areas. Maintain compliance with EU Annex 1, aseptic techniques, cleanroom behavior, and contamination control best practices. Provide QA oversight for commissioning, qualification, and validation (CQV) activities. Evaluate deviations, CAPAs, and change controls—supporting thorough investigations and root-cause analysis. Participate in GMP walkthroughs, on-site quality checks, and aseptic observations. Act as a key QA partner for engineering, production, microbiology, and validation teams—driving qualification excellence. Champion data integrity and continuous improvement initiatives for sterile manufacturing. Deliver training and guidance on aseptic behavior and EU Annex 1 expectations. Requirements: Bachelor’s or higher in Pharmacy, Life Sciences, Engineering, or a related field. 3+ years’ QA experience in GMP pharma, with strong background in qualification/validation and sterile environments. Deep understanding of EU Annex 1 and aseptic operations. Excellent communicator, detail-oriented, and fluent in Spanish and English. Join us and make your mark by advancing quality and safety in pharmaceuticals!
