Qa Specialist (Prd) – Investigations, Crs, Capas & Floor Oversight
hace 3 días
Burgos
ppbPosition: /b QA Specialist (PRD) – Investigations, CRs, CAPAs Floor Oversight /p pbLocation: /b León (on-site) /p pbExperience: /b At least 3 years’ experience in similar roles within the Quality department in pharmaceutical industrial settings /p pWe are looking for a QA Specialist (PRD) – Investigations, CRs, CAPAs Floor Oversight who is passionate about the industrialisation of new products. /p h3General Responsibility /h3 pEnsure 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. /p h3Specific Responsibilities /h3 ul liLead and manage quality investigations related to deviations associated with production activities. /li liPerform and support root cause analysis, ensuring robust identification of underlying causes and appropriate documentation of findings. /li liEvaluate the impact of deviations on product quality, manufacturing processes and GMP/regulatory compliance. /li liCoordinate cross‑functional investigation activities with Production, Engineering, Quality Control, Maintenance and other relevant departments. /li liReview, assess and approve change requests/change controls, ensuring proper justification, impact assessment and implementation in line with GMP requirements. /li liEnsure that change controls are adequately evaluated, approved, implemented and closed within established timelines. /li liReview and approve CAPA plans derived from investigations, audits and inspections, ensuring actions are appropriate and sustainable. /li liMonitor CAPA implementation and verify effectiveness prior to closure. /li liProvide routine QA floor oversight through regular presence in production areas, supporting real‑time decision‑making and compliance with approved procedures. /li liSupport production teams during critical operations, helping resolve GMP issues promptly and reinforcing quality culture on the shop floor. /li /ul h3Experience (area) /h3 pQuality Assurance in GMP‑regulated pharmaceutical or biotechnology manufacturing environments, with strong exposure to production‑related quality activities. /p h3Personal Skills /h3 ul liAdaptability to change and flexibility /li liSpeed without compromising on quality /li liLeadership and teamwork /li liEffective communication /li liCompliance, integrity and sustainability /liliGrowth mindset /li liBusiness focus /li /ul h3Our Benefits /h3 ul liPermanent contract /li liCareer progression and development within a growing international group /li liOngoing training and an innovative working environment /li liSubsidised canteen and other employee benefits /li /ul pCOMMITMENT 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