Qa specialist gmp – qualification & single use

Brabant Wallon - Contracting (Permanent Contract OR Freelance)

For our client specialised in the pharma sector, we are looking for a QA Specialist GMP – Qualification & Single Use.

Context:

The role is part of a major CAPEX project at a pharmaceutical manufacturing site, focused on the construction, qualification, and operational readiness of a new GMP facility dedicated to gene therapy. The project (launched in 2021) is now entering its final, inspection-driven phase, with the objective of obtaining health authority approval to initiate clinical GMP production.

The hiring need is driven by the adaptation of the team to this critical stage, with a strong focus on inspection readiness and the completion of qualification activities, particularly related to Single Use technologies.

Responsibilities:

The position involves:

• Providing QA oversight on equipment qualification & validation (autoclaves, washers).
• Acting as QA partner for Single Use Assemblies (SUA) across lifecycle activities (supplier qualification, verification, risk assessment).
• Finalizing qualification documentation, procedures, and risk assessments.
• Supporting GMP & inspection readiness, ensuring the facility is fully auditable.
• Managing deviations, risks, and quality decisions in a fast-evolving, non-linear project environment.

The day-to-day requires strong interaction with project stakeholders and adaptability to shifting priorities driven by regulatory readiness.

Years of experience (position / total) :

• Around 5 to 8+ years in QA within GMP manufacturing (guideline).
• However, flexibility is possible if the candidate demonstrates strong expertise in Single Use and inspection environments (which are the two most important points).

Focus is more on skills and expertise than strict years.

Must have :

• Strong expertise in Single Use technologies (critical & priority skill).
• Solid experience in GMP QA oversight.
• Experience with qualification/validation activities.
• Exposure to health authority inspections / inspection readiness.
• Ability to take autonomous, pragmatic decisions under pressure.
• Fluency in English & French (both required).
• Strong knowledge of GMP regulations (CFR, Eudralex).

Nice to have :

• Experience with autoclaves and automatic washers.
• Experience in new facility/start-up environment.
• Background in biopharma or gene therapy manufacturing.
• QP certification (considered relevant but not mandatory).
• Broad transversal QA exposure rather than narrow specialization.

Homeworking :

• ~80% on-site presence required
• Limited flexibility depending on the week, but strong on-site presence is key due to the project phase and team dynamics.