Position Description:
We are now seeking Quality Assurance and validation Engineer with the follow expected skills:
Provides knowledge and experience in Quality Systems and/or Operational Quality such as the following i.e., Deviation/ Change Control /Laboratory Investigations / Environmental Monitoring etc.
Performs Batch Disposition preparation, Batch record review, Certification process oversight.
Strong cGMP and regulatory requirement understanding.
Experience in Trackwise.
Support all quality and compliance requirements for and leading to commercial manufacturing.
Uses knowledge to improve Quality Systems and/or Operational Quality with clients; solve complex problems and provide guidance and support for continuous improvement.
Understands and applies regulatory / compliance requirements to the role ensuring alignment and recommendation with current or upcoming regulatory and compliance changes.
Interprets client’s needs, assesses requirements, and identifies solutions to non-standard requests.
Ensure the highest Quality, Compliance and Safety standards
Works collaboratively to facilitate client and ensure alignment and best practices adopted for Quality System related topics and/or Operational Quality
Excellent oral and written English are required.
Available for travel in Italy and abroad.
La selezione rispetta il principio delle pari opportunità (l. 903/77)