QA Downstream Specialist
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QA Downstream Processing Specialist
Walloon Brabant, Belgium
All potential candidates should read through the following details of this job with care before making an application.
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:
- Olivia Braszko, TA Specialist, will analyze your resume 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.
Interested? xlxgzvr
Apply directly via this post and let's discuss your motivation through a first teams meeting
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