GMP QA Release Specialist — Flexible Schedule

Galenicum; Cataluña; Presencial; EUR 42.000 - 60.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance

Flexible schedule

Training program Galenicum Laude

Meal subsidies

Gym facility

Buddy program

Descripción de la vacante

Galenicum is seeking a Quality Assurance Release Expert to join our Quality Assurance Team. You will oversee release activities, review CoAs, BMR/BPR, and manage documentation to ensure GMP compliance.

You will drive corrective actions, support QA reviews of QTA with customers and suppliers, manage deviations and CAPA, and stay up to date with GMP regulations. English and Spanish fluency required.

Formación

• Bachelor's degree in Pharmacy or related field.
• 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

GMP knowledge

Educación

Bachelor's degree in Pharmacy or related field

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 Quality Assurance Team. You will oversee release activities, review CoAs, BMR/BPR, and manage documentation to ensure GMP compliance.

You will drive corrective actions, support QA reviews of QTA with customers and suppliers, manage deviations and CAPA, and stay up to date with GMP regulations. English and Spanish fluency required.