Experience: At least 3 years’ experience in similar roles within the Quality department in pharmaceutical industrial settings
Compruebe que cumple con los requisitos de habilidades para este puesto, así como con la experiencia asociada, y luego envíe su CV a continuación.Position OverviewWe are looking for a QA Specialist (PRD) – Investigations, CRs, CAPAs & Floor Oversight who is passionate about the industrialisation of new products.
General ResponsibilitiesEnsure 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.
Specific Responsibilities
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- Lead and manage quality investigations related to deviations associated with production activities.
- Perform and support root cause analysis, ensuring robust identification of underlying causes and appropriate documentation of findings.
- Evaluate the impact of deviations on product quality, manufacturing processes and GMP/regulatory compliance.
- Coordinate cross-functional investigation activities with Production, Engineering, Quality Control, Maintenance and other relevant departments.
- Review, assess and approve change requests/change controls, ensuring proper justification, impact assessment and implementation in line with GMP requirements.
- Ensure that change controls are adequately evaluated, approved, implemented and closed within established timelines.
- Review and approve CAPA plans derived from investigations, audits and inspections, ensuring actions are appropriate and sustainable.
- Monitor CAPA im

📌 QA Specialist (León)
🏢 Chemo
📍 León