Join Cytiva as a Senior QA Specialist at our Stevenage site UK, where you'll ensure compliance with the Quality Management System while supporting cross-functional projects. This role is pivotal in driving improvements and overseeing essential QA processes that impact life sciences and biotechnology.
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
Participate and actively drive improvement activities within the 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