QA/Validtion Engineer

Posted 7 Hours Ago
Be an Early Applicant
Milano
Hybrid
Entry level
Healthtech • Pharmaceutical
The Role
The Quality Assurance and Validation Engineer will enhance operational quality, ensure compliance with cGMP and regulatory standards, and oversee batch disposition and documentation processes. They will work collaboratively to meet client requirements and drive continuous improvement in quality systems while ensuring safety and quality practices are upheld.
Summary Generated by Built In

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)

The Company
HQ: Indianapolis, IN
923 Employees
On-site Workplace
Year Founded: 1996

What We Do

Fundamentally we exist for one reason: To be the trusted solution for our clients as they strive to build a better working world and improve the human experience.

We are 800+ global experts that bring top-tier expertise to every stage of a project, from creating comprehensive, detailed project plans to eliminating that last punch list item and beyond, into rigorous asset management, reliability, and sustainability activities. We are your choice regardless of your location.

Philosophically and practically, we believe that quality, cost, and schedule can be mutually reinforcing – trade-offs are not necessary. Short-changing the focus on quality usually means problems down the road – problems that can cost money and delay the schedule. But if quality is built in from the start, then both project delivery and operational efficiency can be achieved with a much higher degree of assurance.

When your project requires planned, managed, and documented high quality to exacting global standards. When you need high-performance teams on mission-critical projects. When your project is complex, high-visibility, and carries significant risk. We can help you meet a higher standard.

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