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Quality Assurance Engineer - Italy  

Lilly (company)


Posted on : 12 June 2017

Project Description

  •  Provides 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, Utility 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 utility systems life-cycles
  • Ensure Q process monitoring (alarms mgmt) and in the Utilities module and maintenance board.Collaborate to the alarms classification
  • Approves appropriate qualification/validation on facilities and Utility systems within the set deadlines
  • Approves the maintenance program, the Preventive Maintenance Plan and work instruction (if applicable)
  • Facilitates decision making on the design and quality aspects of the Projects/systems in scope
  • Cooperates in the investigation of deviation equipment/maintenance related
  • Implement corrective action plans to avoid recurrences of deviations utilities/maintenance related
  • Approves change control activities of maintenance/improvement program
  • Approves deviations equipment/maintenance related
  • Review and approve Utilities /maintenance SOPs
  • Plan the activities related to shut down 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.
  • Review metrics and participate in the appropriate process team
  • Collaborates with the Inspection program
  • Respects the compliance with health & safety procedures. 

Language: Fluent English
Experience:Experience on manufacturing activities
Knowledge of manufacturing computer systems;
Knowledge of Quality environment;
Knowledge of Production processes;Certification CSQA