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Qc specification specialist

Braine-l'Alleud
Ucb Pharma
Publiée le 20 mai
Description de l'offre

Make your mark for patients

We are looking for a Quality Control Specification Specialist who is structured, collaborative, and quality‑driven to join our Quality Control (QC) team, based at our UCB campus located in Braine‑l’Alleud, Belgium.

About the role

In this role, you will take ownership of QC specifications, sampling plans, and related documentation for the Braine site. You will ensure ongoing compliance with GMP, regulatory requirements, and internal quality standards, supporting reliable product release and supply continuity.

You will actively manage specification‑related change controls, coordinate inputs from multiple stakeholders, and ensure lot updates meet the needs of Supply Chain and Qualified Persons (QPs). Through your work, you will contribute directly to operational excellence, audit readiness, and continuous improvement within QC processes.

Who you will work with

You will work closely with QC laboratories, Quality Assurance, Regulatory Affairs, Manufacturing, Supply Chain, MSAT, and Qualified Persons. Acting as the primary QC contact for specification, sampling plan and lot updates topics, you will collaborate daily in a matrix environment, ensuring alignment between local Braine teams and global QC functions through clear communication and shared priorities.

What you will do

1. Develop, review, and maintain QC specifications for raw materials, intermediates, and finished products
2. Define, implement, and maintain sampling plans in line with GMP and regulatory guidelines
3. Manage specification‑related change controls, including impact assessments and implementation actions
4. Update lot information and communicate changes effectively to QC laboratories and key stakeholders
5. Coordinate inputs from cross‑functional teams to ensure local and global alignment
6. Support audits, inspections, and continuous improvement initiatives as a subject matter expert for specifications and sampling

Interested? For this role, we are looking for the following education, experience, and skills:

7. Bachelor’s degree in a scientific discipline (chemistry, pharmacy, biotechnology) or equivalent relevant experience
8. Experience in GMP Quality Control, including specifications, sampling plans, and documentation systems between 8- 10 years min
9. Solid understanding of regulatory requirements (ICH, FDA, EMA) and compliance principles
10. Strong organisational skills with the ability to manage priorities, KPIs, corrective actions, and deadlines in a dynamic environment
11. Proven ability to coordinate stakeholders across cross‑functional and matrix organizations
12. Fluent in English and French, with clear written and verbal communication skills

Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you!

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