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QA Engineer

47786
QA Engineer
Firenze
Europe; Middle East; Africa
Italy
Eli Lilly is looking for a QA Engineer to provide quality focused engineering support to develop and maintain validation /maintenance strategy ensuring it is compliant with Eng Standards, LQS, LQP and Local SOP.

MAIN RESPONSIBILITIES:
  • Ensure commissioning and qualification phases of utilities systems and ensure that systems remain validated throughout the life cycle of the system
  • Support cross-functional teams to investigate and address manufacturing non conformances engineering/utilities/maintenance related
  • Support investigation by conducting problem solving and root cause analysis to address engineering/Utilities/maintenance failures identified
  • Identify, create, maintain and publish FUME (Facility, Utilities, Maintenance and Engineering) quality trends
  • Provide interpretation of GMP standards, LQS, LQP ,GQS, Engineering standards and Local SOP from the design to the maintenance of a system and guarantee their implementation on HVAC, Utilities systems
  • Develops risk assessment approaches to specific cases when necessary
  • Ensures and/or performs the QA support for the verification of the qualification and validation activities on facilities and utilities systems lifecycles
  • Approves appropriate qualification / validation on facilities and Utilities systems within the set deadlines
  • Approves the maintenance program, the Preventive maintenance Plan and work instruction (if applicable)
  • Cooperates in the investigation of deviation equipment/maintenance related
  • Implement corrective action plans to avoid recurrency of deviations utilities/maintenance related
  • Approves change control activities of maintenance/improvement program
  • Plan the activities related to shutdown and return to service in collaboration with Sterility assurance
  • Collaborate to guarantee the compliance of the activities of the dept respect to the Q gap analysis.
47786BR
  • Master’s degree in Engineering (Chemical preferred)
  • Fluent in English
  • Experience on manufacturing activities
  • Knowledge of manufacturing computer systems and Quality environment
  • Ability to take initiative, prioritize in a fast moving environment and work independently
  • Attitude to team working and to coordinate activities and people