QA Technical Specialist - GMP Compliance & Audits

Chemo; Madrid; Presencial; EUR 32.000 - 52.000; Jornada completa

Descripción de la vacante

INSUD PHARMA is seeking a QA professional for the Technical Department in León. The role requires a degree in Pharmacy or Chemistry, 2+ years in QA, and strong knowledge of EU and US GMPs. English is required and Spanish bilingualism is preferred.

The candidate will review quality agreements, manage supplier qualification, support audits, and help develop GMP documentation to ensure compliance with internal and external regulations. This position is based in León, Spain.

Formación

• Education: Degree in Pharmacy or Chemistry or Sciences.
• Languages: Intermediate or high level of English and bilingual in Spanish.
• Experience: A minimum of 2 years’ experience in similar position for a senior position.
• Specific Knowledge: Knowledge of EU & US GMPs, quality systems in pharmaceutical companies.

Responsabilidades

• Review, negotiate and manage Quality Technical Agreements with customers, suppliers & third parties and services.
• Supplier’s qualification management: risk analysis performance, register update, annual audit plan preparation and follow up, evaluation of the documental compliance, approval and certification status follow up, supplier status update on SAP system.
• Receipt, filling and delivery to customers of quality questionnaires to be filled by QA.
• ICH Q3D and nitrosamine reports review and management.
• Elaborate and follow-up self-inspections program and conduct self-inspections.
• Support and external audits and inspections according to assess the quality of the GMP system.
• Develop standard operating procedures to ensure steps are collected and comply with regulations.
• Management of GMP documentations and related archive.
• Support and collaboration with the different activities related to the Qualified Person
• Review and management of quality related registration documents.

Conocimientos

GMP knowledge

Quality systems

Supplier management

QA documentation

Regulatory compliance

Educación

Degree in Pharmacy or Chemistry or Sciences

Descripción del empleo

INSUD PHARMA is seeking a QA professional for the Technical Department in León. The role requires a degree in Pharmacy or Chemistry, 2+ years in QA, and strong knowledge of EU and US GMPs. English is required and Spanish bilingualism is preferred.

The candidate will review quality agreements, manage supplier qualification, support audits, and help develop GMP documentation to ensure compliance with internal and external regulations. This position is based in León, Spain.