h3About the Role /h3 pWe are seeking an experienced bQA Specialist /b to support quality oversight activities across external manufacturing partners. The role focuses on ensuring compliance with GMP requirements, maintaining quality systems, and managing quality events related to commercial pharmaceutical products. /p h3Key Responsibilities /h3 ulliOversee quality activities at external manufacturing and testing partners. /liliReview and approve deviations, investigations, change controls, complaints, and validation documentation. /liliSupport batch release activities and product disposition decisions. /liliEnsure compliance with GMP/GDP requirements and internal quality standards. /liliMaintain quality agreements and collaborate closely with contract manufacturers. /liliParticipate in audits, inspections, and supplier quality management activities. /liliMonitor quality metrics, trends, and continuous improvement initiatives. /liliContribute to quality system maintenance, SOP updates, and regulatory inspection readiness. /li /ul h3Required Profile /h3 ulliBachelor's or Master's degree in a scientific discipline. /liliMinimum b3 years of Quality Assurance experience within the pharmaceutical industry /b. /liliExperience with bsterile manufacturing /b is essential. /liliSolid understanding of GMP/GDP regulations and pharmaceutical quality systems. /liliExperience managing quality activities with external manufacturers or CMOs. /liliStrong analytical, problem-solving, communication, and stakeholder management skills. /liliEnglish fluent; German is highly desirable. /liliExperience supporting regulatory inspections and audits is advantageous. /li /ul h3Note /h3 pOccasional travel may be required. /p #J-18808-Ljbffr
QA Senior Specialist Arbeitgeber: Gi Group UK
Unser Kunde in der Region Aarau ist ein hervorragender Arbeitgeber, der Ihnen die Möglichkeit bietet, in einem entwicklungsorientierten Arbeitsumfeld zu arbeiten. Sie profitieren von abwechslungsreichen Aufgaben, einem hohen Gestaltungsspielraum und modernen Anstellungsbedingungen, die Ihre berufliche Entwicklung unterstützen. Hier haben Sie die Chance, Prozesse aktiv mitzugestalten und sich in einem dynamischen Team weiterzuentwickeln.
