Join Cytiva as a Senior QA Specialist and contribute to life-saving innovations in the life sciences sector. You will play a vital role in ensuring compliance with Quality Management Systems while collaborating with cross-functional teams on critical projects. This position offers a unique opportunity to make a real impact in the biotechnology field.
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 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