Drive and perform harmonization of quality procedures and processes across the Injectables division to ensure consistency and efficiency
Perform risk assessments of applicable regulatory guidelines, internal procedures, and quality systems
Work on processes improvements
Monitor and track the progress of projects across injectables sites
Collect and track basic quality metrics from different sites
Prepare simple reports and dashboards
Perform Quality Due Diligences to new businesses
Support audit preparation and execution
Assist in preparing audit reports and responses
Provide support to validation activities across sites for new projects, including revision of documentation
Ensure that departmental Standard Operating Procedures (SOPs) and related documentation are effectively managed, controlled, and compliant with internal and regulatory requirements
Update procedures and quality documents, as applicable
Monitor the training plan and act as Training Coordinator in the database

Degree in Pharmacy or in Life Sciences, Engineering (Biochemistry, Biotechnology)
Strong organizational and documentation management skills
Analytical mindset with the ability to perform risk assessments and support problem-solving
Excellent communication and stakeholder engagement skills
Ability to work collaboratively in a cross-functional and multi-site environment
Proactive approach to continuous improvement and operational excellence
Attention to detail with a strong focus on compliance and quality

Analyst, Quality Systems – Validation

Key skills