QP Delegate (Pharma sector)

Qualified Person (Delegate QP) – Clinical Trial Supplies

📍Walloon Brabant, Belgium

About Nalys

Nalys is a growing consultancy company specialized in high-tech engineering and life sciences. Founded 15 years ago, we partner with leading organizations to deliver innovative solutions and expert support across a wide range of technical domains.

At Nalys, we believe in combining deep expertise with a human-centric approach — empowering our consultants to thrive and our clients to succeed.

Joining Nalys means becoming part of a collaborative, agile, and forward-thinking team that values excellence, innovation, and continuous growth.

Job Description

As a Qualified Person, you will join the Quality Assurance and QP team of a major international pharmaceutical company, at its European hub for clinical trial supplies.

Acting under delegation of the site's Qualified Person, you will certify and release investigational medicinal products used in clinical studies across Europe.

Alongside batch certification, you will play an active role in quality assurance for development activities: managing quality events, contributing to audits and inspections, and supporting partnerships with external manufacturers.

We're looking for a pharmacist with the QP status who wants to put their expertise at the service of clinical research and patients waiting for new treatments.

The Role & Responsibilities

Working within the QA & QP team and in close collaboration with clinical supply, development, regulatory and global quality functions, your responsibilities will include:

• Certifying and releasing clinical trial batches in line with EU and Belgian requirements, GMP and approved product information
• Owning, investigating and approving deviations and change controls
• Approving retest date extensions, study or country additions and QP declarations
• Issuing GMP equivalency confirmations and certification documentation for active substances
• Monitoring quality metrics and escalating any event that could impact product quality
• Taking part in regulatory inspections, partner audits and self-inspections
• Following up CAPAs and supporting product recalls and early access programs
• Depending on experience, taking on additional market-specific release responsibilities.

Skills & Qualifications

• You hold a Master's degree in Pharmacy and the Qualified Person status
• You have at least 1 year of experience in a GMP pharmaceutical environment
• You are familiar with deviation, change control and CAPA management
• Experience with clinical trial supplies or GDP is a strong asset
• A background in production, ideally in advanced therapy medicinal products (ATMP), is a real plus
• You are fluent in English, both spoken and written
• You have a strong quality mindset and communicate issues proactively.

The recruitment process

By applying for the "Qualified Person" position, you will go through the following steps in our recruitment process:

• Olivia Braszko, TA Specialist, will analyze your resume and cover letter and schedule a first screening
• You will have a second interview with one of our Technical Experts
• The last interview will be with our Business Unit Director, Jimmy Rousseaux.

If you have any question regarding this position, feel free to contact directly our Talent Acquisition Specialist : obraszko@nalys-group.com