Quality Program Associate

Quality Program AssociateBarcelonaCompliance & GxP – Compliance /Full-Time /Hybridapply for this jobWho we are   Aizon is a software-as-a-service provider that transforms manufacturing operations in life science industries using advanced analytics and artificial intelligence.We are a fast-growing company entering an exciting new stage of expansion, and we are looking for ambitious new team members who are motivated to directly impact our growth and success. If you want your work to make a visible difference as we scale, this is the place to do it.Aizon is helping pharma manufacturers and CDMOs make better decisions in GMP operations. What makes us different from other manufacturing platforms? We help operations leaders and engineers avoid endless cycles of chasing data in disparate and heavy-handed systems and rapidly understand how to run their manufacturing processes better. We’re solving multiple problems in GMP operations that cost manufacturers millions yearly while accelerating their digital maturity journey. One of our unique capabilities is the ability to operationalize the use of predictive AI models in real time without a big data science staff. We're backed by leading industry and software investor firms with solid industry and technology expertise, giving us the foundation to grow with confidence. Our mission is to improve global health by optimizing how medicines are manufactured so that pharma and biotech companies can provide patients worldwide with the right medicine at the right time and price. Join us if you are motivated to directly impact our company's success and growth path forward and, more importantly, to positively contribute to the life science industry and deserving patients worldwide.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's 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 delivery. Perform internal audits to ensure that the project’s documentation related to the GxP implementation is properly developed and the project is executed according to the GAMP 5 guidelines. Help prepare and organize validation and quality evidence to...