QA Downstream Processing Specialist

?Walloon Brabant, Belgium

About Nalys

Nalys is a growing consultancy specialized in high-tech engineering and life sciences. For over 15 years, we've partnered with leading organizations to deliver expert support across a wide range of technical domains, combining deep expertise with a human-centric approach – empowering our consultants to thrive.

Job Description

As a QA Specialist, you will join the Operational Quality team of a leading biopharmaceutical manufacturing site in Belgium, active in Biologics Drug Substance production.

This mission provides immediate, hands-on support to the Downstream Processing team during a critical period, including an upcoming production shutdown – you'll need to be operational fast.

Reporting to the QA Manager, you will act as a quality partner on the shop floor, working in close daily contact with Manufacturing, Engineering/Troubleshooting, QA Systems, and QA Support. Strong stakeholder interaction and a high on-site presence are essential to this role.

The Role & Responsibilities

Your responsibilities will include:

- Providing QA support to Downstream manufacturing operations on the production floor
- Reviewing and approving GMP documentation, deviations, CAPAs, change controls, and batch records
- Participating in operational quality meetings as a quality partner for production teams
- Investigating quality issues, supporting troubleshooting, and ensuring proper escalation
- Coaching GMP facilitators and contributing to continuous improvement initiatives




- Maintaining strong visibility on the shop floor, alongside Production, Engineering, and QA.

Skills & Qualifications

- You hold a Bachelor's or master's degree in a scientific field (Biotechnology, Chemistry, Pharmacy, Life Sciences, etc.)
- You have minimum 5 years experience in a GMP-regulated environment
- You have an hands-on expertise in Biologics Drug Substance manufacturing, with a focus on Downstream Processing
- You are familiar with key DSP technologies: chromatography, ultrafiltration, filtration, viral filtration
- You are comfortable reviewing GMP documentation, deviations, CAPAs, and change controls
- You are fluent in both French and English
- You are proactive, autonomous, and able to ramp up quickly in a fast-paced environment.

What We Offer

- A human‑scaled consulting company focused on expertise, partnership, and career development
- Long‑term assignments with leading pharmaceutical players
- Continuous learning through technical coaching, training, and knowledge sharing
- A supportive culture that values autonomy, trust, and impact.

The recruitment process

By applying for the "QA Downstream Specialist" position, you will go through the following steps in our recruitment process:

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

Interested?

? Apply directly via this post and let's discuss your motivation through a first teams meeting!

📌 Qa downstream specialist (España)
🏢 Nalys
📍 España