Descripción de la oferta
Setonda Laboratorio, established in 2012 as part of the GMG Group, is a leading pharmaceutical company based in Europe. Specializing in the research, development, and production of innovative pharmaceutical products, Setonda focuses on modern solutions and value-added generics derived from organic, synthetic, and herbal compounds. The company strategically consolidates R&D activities in Spain and collaborates with international pharmaceutical entities at various pre-production stages, from clinical studies to GMP audit preparation. Setonda is committed to delivering high-quality advancements for healthcare providers and patients across Europe.Role DescriptionWe are looking for an experienced Quality Control Manager with a strong R&D background to join our pharmaceutical operations in Spain. The role will be responsible for managing QC activities while closely supporting product development and ensuring full compliance with European regulatory standards.Key ResponsibilitiesLead and manage all Quality Control laboratory activitiesEnsure compliance with EU GMP, ICH guidelines, and relevant regulatory requirementsCollaborate with R&D on analytical method development, validation, and transferReview and approve analytical results, specifications, and protocolsOversee stability studies and ensure proper documentationManage OOS, deviations, CAPA, and change control processesSupport regulatory submissions and inspections (e.g., AEMPS, EMA)Lead, mentor, and develop the QC teamQualificationsDegree in Pharmacy, Chemistry, or related scientific fieldMinimum 5 years of experience in the pharmaceutical industryStrong experience in R&D and analytical method development/validationProven experience in Quality Control managementIn-depth knowledge of EU GMP and regulatory requirementsHands-on experience with HPLC, GC, and analytical techniquesFluent in Spanish and EnglishPreferred QualificationsExperience with Spanish regulatory authority (AEMPS)Spanish language is a plusWhat We OfferCompetitive salary packageOpportunity to work in an international environment
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