Associate-Quality Assurance-1

at  Elanco

JOB TASKS:

• Implementation, assurance and monitoring of GMP status and regulatory requirements for computerized systems (CS) in their life cycle
• Supervision of validation of CS and verification of global CS applications at the site
• Collaboration with global CS validation team
• Data analysis and data management
• Implementation of quality assurance-related activities
• Performance of self-inspections
• Processing deviations, changes and root cause analyses
• Creation of quality-relevant documents (SOP, risk analysis, etc.)
• Reviewing and approving documents in accordance with SOP specification
• Ensuring good documentation practice in accordance with GMP
• Implementing operational excellence management and a culture of continuous improvement as well as establishing measures to prevent incidents
• Collaboration in cross-functional and cross-organizational projects