QA Technical Specialist – GMP & Supplier Quality (León)

Chemo; Castilla y León; Presencial; EUR 32.000 - 42.000; Jornada completa

Descripción de la vacante

InsudPharma León, in the QA Technical Department, is seeking a QA professional with 1–3 years’ experience to manage quality agreements, supplier qualification, and regulatory compliance. The role demands knowledge of EU/US GMPs and strong documentation discipline.

Responsibilities include conducting self-inspections, supporting external audits, developing SOPs, and ensuring GMP documentation is current. Fluent Spanish with English proficiency is desirable.

Formación

• Education: Degree in Pharmacy, Chemistry or Sciences.
• Languages: English (intermediate/high) and bilingual in Spanish.
• Experience: minimum 2 years in a similar QA role.
• Knowledge: EU & US GMPs and quality systems in pharma.

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 (general quality and departmental) to ensure that the steps are collected in each case and comply with internal and external regulations applicable in each case.
• 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

English language

Attention to detail

Analytical mindset

Communication

Teamwork

Compliance mindset

Educación

Degree in Pharmacy or Chemistry or Sciences

Descripción del empleo

InsudPharma León, in the QA Technical Department, is seeking a QA professional with 1–3 years’ experience to manage quality agreements, supplier qualification, and regulatory compliance. The role demands knowledge of EU/US GMPs and strong documentation discipline.

Responsibilities include conducting self-inspections, supporting external audits, developing SOPs, and ensuring GMP documentation is current. Fluent Spanish with English proficiency is desirable.