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Quality assurance officer temporal (málaga)

Málaga
Temporal
Oxford Global Resources
Publicada el 6 abril
Descripción

?? NEW OPPORTUNITY – Temporary QA Specialist (Pharma)?? On-site | Sant Cugat (Barcelona)?? Contract: End May **** – December ****Oxford Integral Resources – Life Sciences Unitis supporting one of the fastest-growing pharmaceutical companies headquartered in Spain, recognized for its strong commitment to innovation and R&D; excellence.We are currently looking for an experiencedQA R&D; Specialistto join theirQuality Assurance – Pharmaceutical Developmentteam on a temporary basis.??Role: QA Specialist – R&D; (GMP, IMPs, Quality Systems)??Location: Sant Cugat (on-site)??Start: ASAP | ?? Full-time, long-term project??Experience: Minimum 3–4 years in a similar QA R&D; GMP role?? Sector: Pharmaceutical | GxP | Clinical Trials | IMPs??Main Responsibilities?? Review and/or approval of key GMP documentation generated by the Pharmaceutical Development area, including:Manufacturing, packaging, and labeling instructions for IMPsAnalytical methods, specifications (LIMS), and specification dossiersICH stability protocols/reportsMethod validation documentationShelf-life justification reports for IMPsDeviation and change control managementMaster Manufacturing Plans (MMP & MMPr)SOPs for equipment cleaning, operations, and room proceduresQualification protocols/reports for analytical equipment?? Support the Quality Management System (QMS):Deviation handling, CAPAs, change controls, complaintsInvestigations of OOS, OOE, OOT and related CAPA evaluationEdition and maintenance of Quality AgreementsSOPs and controlled documents related to Quality & R&DArchiving; and documentation management for GxP-relevant activities?? Monitor the status of IMPs throughout the clinical supply chain (manufacturing to end-of-trial)?? Participate in audits (internal/external) and inspections?? Manage submissions to AEMPS as needed (manufacturing/import/export, controlled substances)?Your ProfileBachelor's or Master's degree in Pharmacy, Chemistry, Biotechnology, or similar3–5 years of experiencein QA

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