The Position
Report to: Quality and Compliance Manager
This is an early-career opportunity to join Aizon's Quality & Validation function and support the delivery of our GxP software solutions into highly regulated pharmaceutical manufacturing environments. Working closely with senior quality, validation, and delivery colleagues, you will help build and maintain the quality program that underpins our customer implementation projects, from quality planning and computer system validation (CSV/CSA) to documentation and inspection readiness. The scope of this role is to ensure that projects derived from the implementation of Aizon’s products are properly implemented in GxP environments.
The role is a key contributor to Aizon's success: by ensuring our projects meet GMP and regulatory expectations, you help our customers go live faster and with confidence, protecting data integrity and, ultimately, supporting the safe and timely delivery of medicines to patients. It is also a great launchpad to grow into more senior CSV, QA, or project delivery roles.
Key Responsibilities
- Support the creation, maintenance, and execution of quality plans for customer implementation projects, ensuring alignment with GMP/GxP requirements.
- Assist in computer system validation (CSV/CSA) activities for Aizon solutions, helping draft and execute validation deliverables (validation plans, requirements and specifications, IQ/OQ/PQ test protocols, traceability matrices, and validation summary reports).
- Help coordinate GMP implementation projects: tracking deliverables, timelines, and action items across internal and customer teams.
- Provide support on validation and compliance consulting engagements, helping gather customer requirements and translate them into quality and validation documentation.
- Maintain documentation and records in line with data integrity (ALCOA+) and good documentation practices (GDP).
- Assist with change control, deviation, and CAPA documentation related to project
📌 Quality Program Associate (España)
🏢 Medium
📍 España