QP & RP batch release
Qualified Person and Responsible Person support for batch release. Clear decision rationale, control over deviations and a fully traceable chain.
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.
From batch release to pharmacovigilance: six connected domains for companies in the pharmaceutical, cosmetics and food sectors across Europe and the United Kingdom.
Qualified Person and Responsible Person support for batch release. Clear decision rationale, control over deviations and a fully traceable chain.
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.
Practical support for QA staff in handling deviations, change management and preparing and maintaining clear, usable documentation.
Computer System Validation and process validation with a risk-based approach. Qualification of installations and processes: measurable certainty, no bureaucratic ballast.
Guidance on registrations, variations and dossier management. Oversight of obligations so your product reaches the market compliantly and stays there.
Setting up and managing pharmacovigilance processes. From detecting safety signals to reporting adverse reactions, with reliable follow-up of safety data.
Operational and leadership experience across QA (Quality Assurance), RA (Regulatory Affairs) and PV (Pharmacovigilance).

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.

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.
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.

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.

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

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.

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.
systems validated
batch backlog cleared
supplier audits
inspections with regulatory authorities supported
Kaizen is the philosophy behind Qaizen Consulting: continuous improvement, pragmatic efficiency and reliable quality.
Map bottlenecks and risks. Clear priorities and a well-defined scope before the start.
Reduce complexity and focus on what works. Practical processes the team understands and can apply.
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.
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.
Confidentiality goes without saying. Your details are only used to answer your request.