Position Description:We are now seeking a Quality Assurance and Validation Engineer with the following expected skills:Provides knowledge and experience in Quality Systems and/or Operational Quality such as the following: Deviation, Change Control, Laboratory Investigations, Environmental Monitoring, etc.Performs Batch Disposition preparation, Batch record review, and Certification process oversight.Strong understanding of cGMP and regulatory requirements.Experience in Trackwise.Supports all quality and compliance requirements for and leading to commercial manufacturing.Uses knowledge to improve Quality Systems and/or Operational Quality with clients; solves complex problems and provides guidance and support for continuous improvement.Understands and applies regulatory/compliance requirements to the role, ensuring alignment and recommendations with current or upcoming regulatory and compliance changes.Interprets client’s needs, assesses requirements, and identifies solutions to non-standard requests.Ensures the highest Quality, Compliance, and Safety standards.Works collaboratively to facilitate client engagement and ensures alignment and best practices are adopted for Quality System related topics and/or Operational Quality.Excellent oral and written English are required.Available for travel in Italy and abroad.
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