QA TECHNICIAN (QA SYSTEMS)

Chemo; Azuqueca de Henares; Presencial; EUR 36.000 - 48.000; Jornada completa

Descripción de la vacante

Chemo, part of the Insud Pharma group, seeks a QA Technician for our LICONSA plant to ensure GMP and regulatory compliance. You will actively participate in CAPAs, CCs, and complaints management, and support PQRs and supplier homologation under internal procedures.

Requirements include a Pharmacy/Chemistry/ Sciences degree, 3+ years in a similar role, and English proficiency with Spanish fluency. Knowledge of EU/US GMPs and SAP/Trackwise is valued.

Formación

• Degree in Pharmacy, Chemistry or Sciences.
• Minimum 3 years’ experience in a similar position.
• Intermediate or high level of English; bilingual in Spanish.

Responsabilidades

• Raw material suppliers homologation and system maintenance; conduct risk assessments.
• Quality complaints: register, investigate and respond; identify recurrence.
• PQR preparation according to annual plan timelines and procedures.
• CAPA and CC: register, evaluate and follow up tasks.
• Provide GMP training to new staff; training records.
• Prepare or update SOPs related to activities in charge.
• Support external audits from customers and authorities; assist shelf inspections.

Conocimientos

Quality systems

CAPA/PQRs

Audits

GMP compliance

Documentation

Educación

Degree in Pharmacy or Chemistry or Sciences

Herramientas

SAP

Trackwise

Descripción del empleo

Insud Pharma is a recognised and respected company in the pharmaceutical and healthcare sector with more than 40 years of history and more than 7,000 employees in 50 countries specialising in the research, development, manufacture and marketing of active pharmaceutical ingredients and medicines for human and veterinary use.

Chemo, industrial area of the Insud Pharma group, is a world leader in R&D and manufacturing of more than 100 value-added active pharmaceutical ingredients and more than 122 medicines with more than 200 different product presentations. Chemo produces its own active pharmaceutical ingredients (API) as well as finished pharmaceutical products (FDF) covering the main therapeutic groups (Cardiology, Gastroenterology, Central Nervous System, Anti-infectives, Respiratory, Women's Health, Endocrinology, Dermatology and Urology).

We are looking for a QA TECHNICIAN for our plant, LICONSA

Overview

Assure compliance of GMP, regulatory and internal standards according to quality policies and applicable requirements within the organization. Actively participate in the CAPAs, CCs and complaints management, preparation of PQRs, supplier homologation and update in accordance to internal procedures, GMPs rules, Authorities and customers requirements. EU & US GMP compliance.

Global Responsibility

• Raw material suppliers homologation and sytem maintenance, risk assessment performance. Audits annual plan preparaton and support regarding the audit performance. The role is a contact person of the company regarding quality queries to be managed with raw material suppliers or external services.
• Quality complaints from customers: register, investigation and response. Recurrence and tendency identification.
• PQR preparation according to timelines included in the annual plan, internal procedures and TA in force.
• CAPA and CC system: register, evaluation and follow up. Performance of the specific task assigned to.
• Training: GMP basic training to new staff. Register and follow up.
• SOPs: to prepare or update specific SOP related to the activitivities in charge of.
• Collaborate in external audits from customers and Authorities and conduct shelf- inspections according to the annual plan.
• Support to Customers and Authorities request for quality and technical issues.

• Education: Degree in Pharmacy or Chemistry or Sciences.
• Languages: Intermediate or high level of English required and bilingual in Spanish.
• Experience (years/area): A minimum of 3 years’ experience in similar position.
• Specific Knowledge: Knowledge of EU & US GMPs, quality systems (CAPAs, PQRs, audits support,suupplier managment, change controls, etc.) in pharmaceutical companies. SAP and Trackwise knowledge is valuable.

COMPROMISO CON LA IGUALDAD DE OPORTUNIDADES