Quality Assurance Release Expert
La información a continuación detalla los requisitos del puesto, la experiencia esperada del candidato y las cualificaciones correspondientes.
Release activities by reviewing CoAs, Manufacturing & Packaging Records (BMR, BPR) and managing related documentation.
Propose and manage corrective actions focusing on continuous improvement.
Support review of Quality Technical Agreements with customers and suppliers.
Manage deviations and customer/supplier claims.
Manage changes, incidents, and nonconformities.
Keep updated on GMP regulations and evaluate impact on the Quality System and activities.
Participate in external audits to CMOs related to own release products, including audit execution, review, CAPA plan evaluation, and follow‑up.
Follow up periodically with customers for designed release products.
Qualifications
GMP knowledge.
Minimum 3 years’ experience in a GMP environment.
Preferred ...