Validation & Qualification

Full compliance, time and again.

How can we help our clients with Validation & Qualification?
First, we listen to our client and capture their exact expectations in a User Requirement Specification document. Based on this and other documents, as well as rules and guidance (GxP, USP, EudraLex, …), we perform Validation & Qualification using the V-model.

Whether our consultants need to validate equipment, complex software, data integrity, … Pauwels Consulting has the necessary expertise to perform Validation & Qualification checks in a critical, structured and rigorous fashion. The tools we use include SAP, DeltaV, TrackWise and True Vault.

What is our added value as Pauwels Consulting?
Thanks to the vast experience our consultants gained working on diverse projects, we know all the best practices and can employ them in our clients’ projects. We know the typical flaws in many software suites and pieces of equipment, helping us to validate and qualify them efficiently for their exact usage.

No matter the context and the exact nature of a project, our consultants are experienced, analytical and precise, allowing them to validate and qualify any software or equipment successfully, making sure our clients’ products are safe and of the highest quality.

The roles

We are always looking to strengthen our team with the following experts:

Validation Engineer

Our Validation Engineers manage, inspect, calibrate, test and modify the instrumentation, equipment, mechanics and procedures used to manufacture sensitive products such as medicines. They ensure all systems are running correctly and efficiently to produce high-quality products time and again.

Qualification Engineer

Our Qualification Engineers are responsible for performing qualifications and maintaining the qualified state of manufacturing equipment, utilities, facilities and the qualification process.

Data Integrity Engineer

Our Data Integrity Engineers study the entire production process of sensitive products to evaluate whether all data linked to GxP systems (QC and production) and processes are treated and stored as prescribed in the data integrity requirements.

CSV Expert

Our CSV Specialists plan, write, implement and review the Computer Systems Validation protocols in highly regulated manufacturing and pharmaceutical environments. They make sure and provide proof that all computer-based systems are operating as intended according to the regulatory requirements.

“As a validation and qualification consultant, we have to follow strict GxP guidelines. This requires an analytical mindset and great accuracy and care. My job is varied and I have lots of flexibility. My work in validation and qualification is also very rewarding: I am glad that I can contribute to the safe production of qualitative medicines that can help patients worldwide.”

Tom Van Hees

Process Owner Support Commissioning & Qualification

Are you interested?

Do you love Validation and Compliance and are you looking for a new challenge? Let’s get in touch!

Eva Van Reepingen
Eva Van Reepingen Recruitment Consultant Life Sciences