QA/Validation Engineer

CAI; Milano; In loco; EUR 35.000 - 55.000; Tempo pieno

Descrizione del lavoro

A leading company in the quality assurance field is seeking a Quality Assurance and Validation Engineer to improve quality systems and ensure compliance with regulatory standards. The role involves active participation in batch record review, client collaboration, and support for commercial manufacturing, with travel required across Italy and Europe.

Competenze

• Experience in Quality Systems, Deviation/Change Control, Laboratory Investigations.
• Strong understanding of cGMP and regulatory requirements.
• Excellent oral and written English is required.

Mansioni

• Perform Batch Disposition preparation and review.
• Support quality and compliance for commercial manufacturing.
• Facilitate alignment on Quality System topics with clients.

Conoscenze

Quality Systems

Operational Quality

cGMP understanding

Regulatory compliance

Problem-solving

Communication

Strumenti

Trackwise

Descrizione del lavoro

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.

Suitable candidates must be available for travel throughout Italy and some European travel may be required.

La selezione rispetta il principio delle pari opportunità (l. 903/77)