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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