As a Senior QA Specialist at Cytiva, you will play a critical role in ensuring compliance and quality management within cross-functional teams. You'll oversee QMS management, batch release, and represent QA in various projects, all while contributing to life-changing solutions in biotechnology.
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 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
Required Qualifications
Relevant Bachelor degree in chemistry/Pharmacy or equivalent
Experience in a similar QA role within Life Science companies
Experience in project QA
Experience in Qualification activities within automation, equipment, and analytical methods
Experience in risk assessments/FMEA, batch release, and deviations/NC