Global Quality Investigation

hace 1 semana

Sant Just Desvern, España Laboratorio STADA, S.L. A tiempo completo

GLOBAL QUALITY INVESTIGATION Barcelona | Spain | Full-time | Permanent ABOUT US At STADA, we pursue the purpose of "Taking care of people's health as a trusted partner." All our decisions and actions are driven by our purpose, vision, and values. With our wide range of products—including Generics, Consumer Healthcare, and Specialties—we offer patients, doctors, and pharmacists a comprehensive array of therapeutic options. Approximately 13,000 employees embody our values of Integrity, Entrepreneurship, Agility, and One STADA to achieve our ambitious goals and shape a successful future for our company. We continuously expand our objectives in line with our ambitions, driven by passion, commitment, and a growth mindset. Would you like to be part of a successful international pharmaceutical company and grow with us? RESPONSIBILITIES Review and approve investigation reports. Manage systems for archiving GMP and quality documents. Coordinate investigations with responsible partners (internal sites, global and local functions, and CMOs). Review and evaluate investigations related to quality issues for products on the market. Create, review, and approve reports for national competent authorities. Lead Quality Incident Committee Meetings for risk assessment regarding product quality, especially for batches on the market, in cases of OOS results/deviations, and monitor actions taken. In the committee Serve as key contact for specific topics and maintain worldwide communication with Group-owned production sites and contract manufacturers. Maintain metrics to ensure correctness, integrity, and consistency of GxP-critical Quality Data. Lead and review continuous improvement projects; prioritize and implement innovative ideas. Contribute to global quality projects according to agreed plans. Monitor KPIs related to the investigation process. Act as process owner for NONC, CAPA, DEV, or ETM. Lead and review continuous improvement initiatives, prioritize, and drive innovation. Act as deputy team leader in the absence of the team leader, gaining leadership experience by coordinating and supporting the team as needed. EXPERIENCE Pharmacist, pharmaceutical engineer, or individuals with sufficient scientific education and further qualifications. Other required professional knowledge, skills, and experience. English language proficiency – C1 mandatory. At least 2 years of experience as QP, QA, or QC. Investigation experience is a must. Advanced knowledge of MS Office package. Ability to understand and discuss complex topics; strong technical writing skills. Professional experience in the pharmaceutical industry or a comparable position, preferably in quality. STADA offers a competitive environment for personal and professional development within a growing company full of opportunities. Our future projects require dynamic and proactive professionals capable of adding value in a changing environment. Follow us to receive our news #J-18808-Ljbffr

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