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 support customer audits and inspection readiness.

• Support and lead external audits performed by customers on the project documentation related to Aizon Execute and/or Aizon Platform implementation.

• Collaborate with product, engineering, and delivery teams to ensure quality is built into every solution delivery.

• Contribute to the continuous improvement of internal quality program templates, SOPs, and best practices.

The Human We're Looking For:

• Curious and eager to learn and excited to grow in an international, complex, regulated, and fast-moving domain.

• Detail-oriented and organized, you take accuracy and documentation seriously.

• Proactive and reliable, you follow through, take ownership, and flag risks early.

• A clear communicator and team player, comfortable working across technical and non-technical stakeholders, internally and with customers.

• Adaptable, you thrive in a scale-up pace and stay calm with a degree of ambiguity.

• Quality-minded, you understand that doing things right is not bureaucracy; it's how great medicines reach the people who need them.