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Quality control supervisor

Monteroni d'Arbia
Galenica Senese S.r.l. Industria Farmaceutica
Pubblicato il 16 marzo
Descrizione

PpWe are a growing pharmaceutical company specialized in the manufacturing of sterile injectable products with terminal sterilization. We operate both as a manufacturer and as a Contract Manufacturing Organization (CMO), supporting international clients in the development and production of high-quality injectable medicines. /ph3QC Supervisor – Chemical Laboratory /h3h3Key Responsibilities /h3ulliSupervise compliance with EU, FDA, and other applicable regulatory guidelines within the QC department /liliLead and manage analytical method transfers and suitability testing for new products /liliSupervise a team of QC analysts, ensuring high cGMP and GLP standards are consistently maintained /liliEnsure adherence to laboratory schedules and performance targets to meet regulatory and business requirements /liliCoordinate laboratory activities supporting raw materials, in-process controls, finished products, cleaning validation, and stability testing /liliLiaise effectively with Manufacturing, QA, Regulatory Affairs, and other departments to ensure timely completion of activities /liliDrive continuous improvement initiatives within the QC laboratory and quality systems /liliSupport regulatory inspections and customer audits /liliDevelop and maintain training programs, SOPs, validation documentation, and compliance systems /liliProvide day-to-day leadership, coaching, and performance management to QC staff (potentially across multiple shifts) /liliPromote a strong culture of quality, accountability, and safety /li /ulh3Qualifications Experience /h3ulliDegree in Chemistry, Pharmaceutical Chemistry, or a related scientific discipline /liliPrevious supervisory or technical specialist experience in a pharmaceutical QC laboratory /liliExperience in sterile injectable manufacturing is highly desirable /liliStrong knowledge of cGMP, GLP, and regulatory requirements (AIFA, FDA, ISO standards) /liliExperience supporting customer and regulatory audits /liliProven experience in analytical method validation and transfer /liliExperience leading analytical project teams /liliKnowledge of SAP is considered an advantage /liliStrong leadership, communication, and organizational skills /li /ul /p #J-18808-Ljbffr

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