ppbPosition: /b QA Specialist (PRD) – Investigations, CRs, CAPAs Floor Oversight /ppbLocation: /b León (on-site) /ppbExperience: /b At least 3 years’ experience in similar roles within the Quality department in pharmaceutical industrial settings /ph3Want to find out more? /h3pLEONFARMA is part of INSUD PHARMA, a general leader in the pharmaceutical value chain and a benchmark in the research, development, manufacture and marketing of pharmaceutical products that contribute to human and animal health. Our purpose is to transform the industry through innovation, excellence and a commitment to sustainable development. /ph3Ready to be a #Challenger at LEONFARMA? /h3h3What are we looking for? /h3pWe are looking for a QA Specialist (PRD) – Investigations, CRs, CAPAs Floor Oversight who is passionate about the industrialisation of new products. /ph3General Responsibility /h3pEnsure quality oversight of production-related activities in a GMP-regulated manufacturing environment, acting as a key quality partner for operations on the shop floor. The role is responsible for leading and coordinating investigations, change controls and CAPAs, ensuring appropriate risk assessment, impact evaluation and timely closure in compliance with quality and regulatory requirements. In addition, the position provides real-time QA support to production, reinforcing GMP compliance, issue resolution and continuous improvement across daily manufacturing operations. /ph3Specific Responsibilities /h3ulliLead and manage quality investigations related to deviations associated with production activities. /liliPerform and support root cause analysis, ensuring robust identification of underlying causes and appropriate documentation of findings. /liliEvaluate the impact of deviations on product quality, manufacturing processes and GMP/regulatory compliance. /liliCoordinate cross-functional investigation activities with Production, Engineering, Quality Control,



Maintenance and other relevant departments. /liliReview, assess and approve change requests/change controls, ensuring proper justification, impact assessment and implementation in line with GMP requirements. /liliEnsure that change controls are adequately evaluated, approved, implemented and closed within established timelines. /liliReview and approve CAPA plans derived from investigations, audits and inspections, ensuring actions are appropriate and sustainable. /liliMonitor CAPA implementation and verify effectiveness prior to closure. /liliProvide routine QA floor oversight through regular presence in production areas, supporting real-time decision-making and compliance with approved procedures. /liliSupport production teams during critical operations, helping resolve GMP issues promptly and reinforcing quality culture on the shop floor. /li /ulh3Experience (area) /h3pQuality Assurance in GMP-regulated pharmaceutical or biotechnology manufacturing environments, with strong exposure to production-related quality activities. /ph3Personal skills /h3ulliAdaptability to change and flexibility /liliSpeed without compromising on quality /liliLeadership and teamwork /liliEffective communication /liliCompliance, integrity and sustainability /liliGrowth mindset /liliBusiness focus /li /ulh3Our benefits! /h3ulliPermanent contract /liliCareer progression and development within a growing international group /liliOngoing training and an innovative working environment /liliSubsidised canteen and other employee benefits /li /ulh3Do you think this role isn’t for you? /h3pFollow us on LinkedIn and Instagram so you don’t miss out on future career opportunities! #Leonfarma #Challenger #InsudPharma #InsudTalent /ppCOMMITMENT TO EQUAL OPPORTUNITIES AT LEONFARMA, we believe in and act to promote genuine equality of opportunity. We do not discriminate on the basis of gender, ethnicity, religion, sexual orientation, disability or any other characteristic. We value diversity and talent. We’d love to meet you! /p /p #J-18808-Ljbffr

📌 QA Specialist (PRD) – Investigations, CRs, CAPAs & Floor Oversight (Castilla y León)
🏢 Chemo
📍 Castilla y León