As a QA Specialist, CSV plays a pivotal role in ensuring the quality, compliance, and lifecycle management of equipment and computerized systems supporting pharmaceutical manufacturing within project portfolios.
The job involves overseeing qualification and validation compliance for equipment, infrastructure, and computerized systems associated with drug product manufacturing. This includes reviewing and approving commissioning, qualification, and validation documentation to ensure compliance with quality policies and applicable regulations.
In this role, you will provide QA support for major projects, ensuring quality requirements are embedded from concept through design and execution phases. You will also be responsible for ensuring qualification/validation strategies comply with quality policies and applicable regulations.
To succeed in this position, you will need a bachelor's or master's degree in engineering, life sciences, or a related field. You should have significant experience in GMP-regulated environments, as well as demonstrated experience in QA roles focused on CSV and automation.