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Senior clinical packaging operations coordinator (r&d supply chain) | 100% remote

Chaín (Provincia de Pontevedra)
Astek
Publicada el Publicado hace 4 hr horas
Descripción

PAt bASTEK Iberia /b, we are looking for a bSenior Coordinator – TP Packaging Support Operations /b to join our bClinical Supply Chain / RD External Packaging Operations /b team in the bpharmaceutical sector /b. /ppbr/ppThis senior role is critical to ensuring the timely delivery of packaged clinical supplies supporting clinical studies bfrom Phase 1 to Phase 4 /b, working closely with external packaging and labelling partners across a global network. /ppbr/ppb Main responsibilities: /b /ppbr/pulliEnd‑to‑end coordination of outsourced clinical packaging and labelling activities /liliFull accountability for packaging‑related deliverables, including: Packaging request forms, Randomization lists, Batch record review, Material and production traceability in SAP, Stock reconciliation and goods consumption management. /liliReview of technical drawings, PIM documentation, and contract terminations /liliAct as the primary operational interface with Third Party Contractors (TPCs) /liliParticipate in weekly operational meetings (CMO, Planning, CTSM) to ensure timeline adherence /liliOwnership of reporting activities (KPIs, monthly reports) /liliCreate and approve reference clinical and vaccine label content in line with regulatory, translation, and internal process requirements /liliPerform critical quality checks on multilingual label content in collaboration with Quality Assurance /liliSupport cold chain teams (temperature management) and planning teams (capacity and scheduling) /li /ulpbr/ppb Who are you? /b /ppbr/pulliProven experience in clinical packaging and labelling operations, ideally within outsourced environments /liliStrong understanding of RD, GMP, GCP, and GDP requirements /liliExperience working in complex, matrixed, and international organizations /liliSenior mindset with strong leadership, autonomy, attention to detail, and delivery focus /liliAdvanced proficiency with digital tools and reporting systems /liliExperience with systems such as SAP, Veeva, Power BI, Prisym 360° is a strong plus /liliEnglish: bC1 (required) /b /li /ulpbr/ppb Who are we? /b /ppbr/ppSince 2015, Astek Iberia has been accompanying its customers in their development throughout Spain (Madrid, Barcelona, Valencia, Basque Country, Andalusia, Galicia, etc.). /ppFounded in France in 1988, Astek is a global player in engineering and technology consulting, present in five continents and 25 countries. With expertise in a wide range of industrial and service sectors, Astek is an essential partner, supporting its customers in an intelligent deployment of their products and services, and in the implementation of their digital transformation. /ppToday we are more than 8,000 employees, committed every day to promote the complementarity between digital technologies and complex systems engineering. /ppbr/ppbOur style is to have flexible schedules and highly value the well-being of our employees. /b /ppbr/ppbWhy join us? /b /ppbr/p

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