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Life-sciences, cosmetics & food consultancy · Europe and the United Kingdom

A delayed release or an unexpected finding costs more than time. It costs trust.

Qaizen Consulting delivers quality and certainty, so you can grow with peace of mind.

For quality professionals and leaders responsible for products and processes.

Kaizen means: improving purposefully every day, without losing sight of the reliability of your quality process.

QP & RPQA ManagementQA SupportCSV & ValidationRegulatory AffairsPharmacovigilance
My expertise

Six domains that turn quality into a system.

From batch release to pharmacovigilance: six connected domains for companies in the pharmaceutical, cosmetics and food sectors across Europe and the United Kingdom.

01

QP & RP batch release

Qualified Person and Responsible Person support for batch release. Clear decision rationale, control over deviations and a fully traceable chain.

02

QA Management

Interim QA leadership and support for quality management systems. From CAPA management and documentation to well-prepared audits, with a focus on quality and efficiency.

03

QA Support

Practical support for QA staff in handling deviations, change management and preparing and maintaining clear, usable documentation.

04

CSV & process validation

Computer System Validation and process validation with a risk-based approach. Qualification of installations and processes: measurable certainty, no bureaucratic ballast.

05

Regulatory Affairs management

Guidance on registrations, variations and dossier management. Oversight of obligations so your product reaches the market compliantly and stays there.

06

Pharmacovigilance

Setting up and managing pharmacovigilance processes. From detecting safety signals to reporting adverse reactions, with reliable follow-up of safety data.

Experience that makes the difference

Hands-on experience that pays off right away.

Operational and leadership experience across QA (Quality Assurance), RA (Regulatory Affairs) and PV (Pharmacovigilance).

2026 · Ongoing

Johnson & Johnson

QA CSV Engineer (freelance)

Geel & Beerse

Freelance QA CSV Engineer with cross-site responsibility for Automation Execution Systems across three facilities. Managing system life cycles, quality events and validation and qualification activities for routine and project changes, including Level 2 and Siemens PCS systems (with MTP libraries), fully compliant with international regulations.

2024 – 2026

Vetoquinol

Responsible Person & QA/RA/PV manager

Niel

Responsible Person for Belgium, the Netherlands and Scandinavia with final responsibility for GDP, QA, RA and PV activities across a broad portfolio of medicinal products and food supplements. Leading the local QA, RA and PV teams, administrative batch release and management of inspections and authority interactions, with a key role in international projects such as warehouse logistics centralisation.

Impact

Three inspections (FAGG, CBG-MEB and FAVV) without critical findings, one of them (CBG-MEB) without any remarks. Led a team of three covering RA, PV and QA.

2020 – 2024

Sopra Steria

Quality & Compliance coordinator

Diegem

Quality assurance consultant at large biotech and pharma companies (including Argenx, Galapagos, Biocartis and Sotera Health): QA improvement projects in operations and release, building quality management systems and leading audits as lead auditor, including remediation strategies after authority inspections.

2018 – 2020

Wase Werkplaats

Qualified Person & Quality manager

Temse

Qualified Person responsible for batch release and end-to-end QA/QC oversight in a GMP environment. Led a team of eight employees, managed audits and inspections and delivered strategic improvement projects, such as the design, construction and validation of a cleanroom and the qualification of equipment and software.

Impact

Led a QA and QC team of eight and an audit team of four, and delivered a cleanroom project from design through validation.

2016 – 2018

QbD

Pharmaceutical consultant

Wilrijk

Consultant with a broad remit for clients in pharma, biotech and medical devices (including Pfizer, Etherna, Plasma Industries Belgium, HDB): QA in operations and release, building quality management systems, lead auditor, and QA CSV expert supporting SaaS and client in-house software development.

2015 – 2016

Wolfs Laboratoria

Trainee Qualified Person

Zwijndrecht

Career start at a pharmaceutical CMO with all activities under one roof: from raw material to finished, packaged product, including food supplements. Broad experience with the pharmaceutical production chain, batch record review, deviation and CAPA management and GMP, in close collaboration with QC and production.

50+

systems validated

100+

batch backlog cleared

20+

supplier audits

10+

inspections with regulatory authorities supported

Approach · Kaizen

Small steps, lasting progress.

Kaizen is the philosophy behind Qaizen Consulting: continuous improvement, pragmatic efficiency and reliable quality.

Step 01

See

Map bottlenecks and risks. Clear priorities and a well-defined scope before the start.

Step 02

Simplify

Reduce complexity and focus on what works. Practical processes the team understands and can apply.

Step 03

Anchor

Clear procedures, responsibilities and controls. Quality as a fixed part of daily operations.

Improvement does not have to be complicated. Every focused step forward strengthens your organisation and delivers lasting quality.

Jeroen Lievens — Qaizen Consulting
Contact

Let's meet.

Looking for temporary support, someone to fill a specific role or advice on a quality issue? Tell us briefly what you need help with. Jeroen will personally get in touch, usually within a few days, with honest and practical advice.

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