As a Senior QA Specialist at Cytiva, you'll play a key role in ensuring compliance and quality in a dynamic environment dedicated to life sciences and biotechnology. You will work collaboratively with cross-functional teams to manage quality processes, drive improvements, and support critical projects. Join us in making a real difference in transforming human health.
Key Responsibilities
Represent QA in cross-functional projects as new product- and equipment projects
Support the organization within the QMS processes; Change Control, CAPA, NC and batch release
Review and approve Change Control, CAPA, NC
Perform batch release
Approve qualification activities to meet set timelines and project plans
Represent QA in cross-functional risk assessments
Review and approve risk assessments and qualification documentation
Drive improvement activities within the QMS, projects and processes
Ensure compliance with the Quality Management System (QMS)
Required Qualifications
Relevant Bachelor degree within chemistry/Pharmacy or equivalent
Experience of similar QA-role within Life Science companies (e.g., ISO 9001, ISO 13485 and/or GMP)
Experience of being QA in projects
Experience of Qualification activities within automation, equipment and analytical methods
Earlier experience as QA in risk assessments/FMEA, batch release and deviations/NC