Quality Assurance Lead

Curapath; Valencia; Presencial; EUR 40.000 - 60.000; Jornada completa

Descripción de la vacante

Curapath, una organización de desarrollo y fabricación a contrato, busca un Quality Assurance Lead para supervisar las actividades de aseguramiento de calidad en su instalación de fabricación. El candidato ideal deberá tener experiencia en la validación de procesos y product release, así como un fuerte conocimiento de las regulaciones GMP y FDA. Este rol ofrece un entorno de trabajo colaborativo y oportunidades significativas de aprendizaje y mejora continua.

Servicios

Ambiente de trabajo agradable

Oportunidades de aprendizaje continuo

Formación

• Más de 5 años de experiencia en operaciones de aseguramiento de calidad en un entorno farmacéutico o biotecnológico.
• Fuerte comprensión de las directrices de FDA, EMA, GMP, e ICH.
• Experiencia en auditorías regulatorias y certificación de lote.

Responsabilidades

• Supervisar actividades de aseguramiento de calidad relacionadas con la liberación de lotes y la validación de procesos.
• Actuar como investigador principal para desviaciones y análisis de causa raíz.
• Garantizar el cumplimiento de las normativas y prácticas de documentación.

Conocimientos

Solución de problemas

Evaluación de riesgos

Liderazgo

Trabajo en equipo

Pensamiento crítico

Educación

Licenciatura o Maestría en Farmacia

Herramientas

Sistemas de gestión de calidad (QMS)

Descripción del empleo

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Who Are We?

Who Are We?Curapath is a full-service CDMO (Contract Development and Manufacturing Organization) that integrates innovative technology with scientific precision, streamlining the manufacturing process from preclinical development to clinical stages. We provide the best drug delivery solutions to potential clients seeking targeted therapies.We believe in science as a force to transform the world, and we strive to create an environment where our team can thrive. That's why we are committed to fostering the growth and development of every individual in our company.Would you like to join our team?We are looking for a Quality Assurance Lead. The Quality Assurance Lead & QP Backup is responsible for overseeing quality assurance activities related to batch release, process validation, deviation investigations, raw material compliance, audits, and GMP compliance within a pharmaceutical manufacturing facility. This role requires expertise in process validation and product release, ensuring compliance with FDA, EMA, GMP, and ICH Q7 / Q10 guidelines. Additionally, this position serves as a backup Qualified Person (QP), assisting with certification of batches for release in compliance with EU GMP.The Key Responsibilities to be performed will be as follows :

• Batch Release & QP Backup Responsibilities
• Ensure compliance of raw materials, excipients, and packaging components with approved specifications.
• Conduct batch record review and QC data verification to ensure timely batch disposition.
• Support batch certification and product release activities.
• Assist the Qualified Person (QP) in ensuring batches meet all regulatory and quality requirements before release.
• Process Validation & QA Oversight
• Review and approve process validation protocols and reports to ensure compliance with validation requirements.
• Provide QA oversight of manufacturing activities, including in-process checks and deviation monitoring.
• Review and approve SOPs, method validation, and technology transfer documentation.
• Support technology transfer and scale-up activities for new products and processes.
• Deviation & CAPA Management
• Act as the Lead Investigator for deviations, non-conformances, and root cause analysis (RCA).
• Ensure timely deviation reporting, investigation, and closure to prevent recurrence.
• Implement corrective and preventive actions (CAPAs) to strengthen compliance and reduce risks.
• Auditing & Compliance Management
• Support customer audits and inspections, ensuring compliance responses are properly addressed.
• Support internal GMP self-inspections to identify risks and process improvement opportunities.
• Ensure adherence to Good Documentation Practices (GDP), GMP, and data integrity principles.
• Review cleanroom environmental monitoring results to ensure compliance with microbiological control standards.
• Support the development of contamination control strategies to maintain aseptic processing compliance.
• Conduct periodic GMP training sessions and assess personnel competency.
• Quality Review & Continuous Improvement
• Oversee the Annual Product Review (APR / PQR) process to track product and process trends.
• Support Annual Quality Management Reviews, analyze operations data, identify gaps, and propose improvement plans.

What do we need?

• Bachelor's or Master's degree in Pharmacy.
• 5+ years of experience in Quality Assurance Operations, including batch release and process validation in a GMP-regulated pharmaceutical or biotech environment.
• Strong understanding of FDA, EMA, GMP, ICH Q7 / Q10, and data integrity guidelines.
• Experience in batch certification, deviation investigation, and regulatory audits.
• Working knowledge of Quality Management Systems (QMS) and validation protocols.
• Familiarity with QP requirements and responsibilities under EU GMP Annex 16.
• Excellent problem-solving, risk assessment, and leadership skills.
• English written and spoken
• Experience in supervision

Competences

• Teamwork
• Commitment
• Flexibility and adaptability
• Critical thinking
• Proactivity
• Time management and scheduling skills

What do we offer?

• Position with a high level of learning and continuous improvement.
• Great work environment.

Seniority level

Seniority level

Mid-Senior level

Employment type

Employment type

Contract

Job function

Job function

Quality Assurance

Chemical Manufacturing

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