QA Release Expert — GMP & Continuous Improvement

Galenicum; Esplugues de Llobregat; Presencial; EUR 42.000 - 64.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance coverage

Flexible remuneration

Gym

Subsidized meals in office restaurant

Training offer

Buddy to help you land smoothly

Office environment

Descripción de la vacante

Galenicum is seeking a Quality Assurance Release Expert to join our QA Team. You will lead release activities by reviewing CoAs, BMRs and BPRs, and managing related documentation, ensuring compliance with GMP standards and internal quality systems.

You will drive CAPA and continuous improvement, review Quality Technical Agreements, manage deviations and supplier claims, and participate in external audits of CMOs. Fluent English and Spanish are required; a Pharmacy degree is essential.

Formación

• Bachelor’s degree in Pharmacy required.
• Master’s degree in Pharmaceutical Industry or related.
• Excellent level of English and Spanish, spoken and written.

Responsabilidades

• Release activities, by reviewing CoAs, Manufacturing & Packaging Records (BMR, BPR) and management of documentation related.
• Proposal and management of corrective actions with focus on continuous improvement.
• Support in the review of Quality Technical Agreements with customers and suppliers.
• Management of deviations and customer/ suppliers claims.
• Management of changes, incidences and nonconformities.
• Keep updated on GMP regulations and evaluate the impact within our own Quality System and activities.
• Participate in external audits to CMOs related to own release products, with execution of audit, review and evaluation of audit reports, CAPA plan evaluation and follow-up.
• Periodic follow‑up of Customers for designed release products.

Conocimientos

Analytical skills

Problem solving

Time management

Team player

Educación

Bachelor’s degree in Pharmacy

Master’s degree in Pharmaceutical Industry or related

Herramientas

MS Office

SAP

TrackWise

Descripción del empleo

Galenicum is seeking a Quality Assurance Release Expert to join our QA Team. You will lead release activities by reviewing CoAs, BMRs and BPRs, and managing related documentation, ensuring compliance with GMP standards and internal quality systems.

You will drive CAPA and continuous improvement, review Quality Technical Agreements, manage deviations and supplier claims, and participate in external audits of CMOs. Fluent English and Spanish are required; a Pharmacy degree is essential.