Manufacturing Lead, EU GMP Operations

vor 3 Wochen

Berlin, Deutschland BioTalent Vollzeit

Manufacturing Lead, EU GMP OperationsPLEASE NOTE: Applicants must be fluent in both German and English and currently based in Germany. You must also have hands-on experience with commercial medicinal products and/or IMPs across solid, liquid, and ideally sterile manufacturing, along with a solid understanding of EU importation and QP release standards.BioTalent are teamed up with a global pharmaceutical organisation that are expanding its EU import and manufacturing oversight function and is looking for a Manufacturing Lead to join the team. The focus of this role is to ensure that imported and manufactured medicinal products meet EU GMP, GDP, and national regulatory requirements, with a strong emphasis on batch review, documentation control, partner oversight, and supporting QP release activities.This is a great fit for someone who enjoys working across manufacturing, QA, external partners, and regulatory expectations, and wants a role with real visibility and impact across EU operations.What you’ll be doing• Managing manufacturing activities in line with AMWHV §12 • Ensuring timely import, testing, and review of batch records • Supporting GMP and GDP compliance across all operational areas • Working closely with external manufacturers, packagers, and contract service providers • Overseeing documentation, deviations, CAPA, audits, and change control • Supporting qualification and validation of equipment, facilities, and processes • Preparing documentation required for QP release • Working with QA and operational teams to streamline and strengthen processesWhat you’ll need• Degree in pharmacy, chemistry, pharmaceutical technology, or a related field • At least 3 years of hands-on pharmaceutical manufacturing experience (solid, liquid, or sterile dosage forms) • Strong understanding of GMP, GDP, and German national regulatory requirements • Experience reviewing manufacturing records and supporting QP release processes • Background working with external manufacturing partners or CMOs • Fluent German and English • Strong organisational, documentation, and problem-solving skills • Willingness to travel occasionally and attend the Munich site when needed

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