Join Cytiva as a Senior QA Specialist and play a crucial role in ensuring compliance and quality management within life sciences and biotechnology. You'll work in a cross-functional team, supporting vital projects that contribute to life-saving solutions, all while fostering continuous improvement in a collaborative environment.
Key Responsibilities
Represent QA in cross-functional projects for new products and equipment
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 project timelines
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 in Chemistry, Pharmacy or equivalent
Experience in a similar QA role within Life Science companies (e.g., ISO 9001, ISO 13485, GMP)
Experience of being QA in projects
Experience in Qualification activities within automation, equipment and analytical methods
Experience in risk assessments/FMEA, batch release, and deviations/NC