As a Senior QA Specialist at Cytiva, you will oversee QMS management and batch release, ensuring compliance while working collaboratively across departments. This role is key in representing QA in projects and driving continuous improvement to transform human health.
Key Responsibilities
Represent QA in cross-functional projects
Support the organization within 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
Represent QA in cross-functional risk assessments
Review and approve risk assessments and qualification documentation
Drive improvement activities within the QMS
Required Qualifications
Relevant Bachelor degree in chemistry/Pharmacy or equivalent
Experience in a similar QA role within Life Science companies
Experience in QA for projects
Experience in qualification activities for automation, equipment, and analytical methods
Experience in risk assessments/FMEA, batch release, and deviations/NC