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BeBee, Black Diamond Networks
Quality Assurance SpecialistBeBee, Black Diamond Networks • Madrid, ES
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Quality Assurance Specialist

Quality Assurance Specialist

BeBee, Black Diamond Networks • Madrid, ES
Hace 12 días
Descripción del trabajo
Responsibilities

¡Inscríbase sin demora! Se espera un gran volumen de solicitantes para el puesto que se detalla a continuación, no espere para enviar su CV.

Review and approve key GMP documentation generated by the Pharmaceutical Development area, including: Manufacturing, packaging, and labeling instructions for IMPs Analytical methods, specifications (LIMS), and specification dossiers ICH stability protocols and reports Method validation documentation Shelf-life justification reports for IMPs Master Manufacturing Plans SOPs related to equipment cleaning, operations, and room procedures Qualification protocols and reports for analytical equipment Manage and support core Quality activities: Deviations, CAPAs, change controls, and complaints Investigations of OOS, OOE, OOT, and related CAPA evaluation Quality Agreements (creation and maintenance) SOPs and controlled documentation for Quality & R&D Archiving and GxP documentation management Monitor IMP status across the clinical supply chain (manufacturing to end-of-trial) Support and participate in internal/external audits and regulatory inspections Manage submissions to AEMPS (manufacturing, import/export, controlled substances)

Requirements Bachelor’s or Master’s degree in Pharmacy, Chemistry, Biotechnology, or a related field xcskxlj 3–5 years of QA experience within an R&D or IMP-focused GMP environment Strong knowledge of ICH guidelines, GxP, and EU GMP Annex 13 Experience collaborating with Manufacturing, Analytical, and Regulatory teams Fluent Spanish and professional English Detail-oriented, proactive, and strong problem-solving mindset Team player with the ability to work in cross-functional environments
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Quality Assurance Specialist • Madrid, ES

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