| Location | Puurs, Belgium |
|---|---|
| Business Sector | Biotechnology |
| Contact email | |
| Job ref | 27039 |
| Published | about 2 hours ago |
QC Geel | Contractor
We are looking for an experienced analytical expert to support non-chromatographic QC laboratories in a commercial small-molecule environment. This role focuses on technical oversight, scientific problem-solving, compliance support, and continuous improvement within a GMP-regulated setting.
The successful candidate will act as a subject matter expert for solid-state and non-chromatographic analytical technologies, supporting laboratory teams, driving improvements, and helping maintain inspection readiness and regulatory compliance.
Provide daily support to supervisors of non-chromatographic release and IPC laboratories.
Lead complex scientific and quality investigations and support CAPA remediation.
Collaborate closely with QA, production, R&D, and regulatory partners to troubleshoot issues.
Drive changes in the non-chromatographic QC area, including change controls and implementation plans.
Prepare, review, and finalize GMP procedures and guidance documents.
Develop fit-for-purpose standards, guidelines, and training materials for the QC laboratory.
Coach laboratory staff on technical and scientific matters.
Monitor laboratory practices and drive continuous improvement in line with industry expectations.
Contribute to working groups and support the implementation of modern analytical approaches such as PAT and RTRT.
Support equipment deviations and coordinate with equipment management and suppliers.
Evaluate and introduce new analytical equipment and technologies.
Support analytical lifecycle management and method transfer activities.
Act as system owner for laboratory instruments and ensure training requirements are met before access is granted.
Maintain GMP compliance and inspection readiness.
Participate in compendial vigilance and local implementation of updates from relevant pharmacopeias.
Act as spokesperson during authority inspections for non-chromatographic laboratories.
We are looking for a professional with:
A Master’s degree in Chemistry, Pharmaceutical Sciences, or a related scientific field. A PhD is preferred.
At least 5 years of experience in small-molecule CMC analytical work.
Experience in analytical R&D, MSAT, industrialization, or late-stage development.
Strong knowledge of product release, stability testing, method validation, method transfer, and compendial verification.
Deep understanding of cGMP and relevant regulatory guidelines, including ICH Q1, Q2, Q3, Q7, Q8, Q9, Q10, Q11, Q12, and Q14.
Hands-on knowledge of non-chromatographic analytical techniques such as:
Particle size distribution / laser diffraction.
XRPD.
Karl Fischer.
Potentiometric titration.
IR spectroscopy.
UV spectroscopy.
Raman.
AAS.
ICP-OES/MS.
Familiarity with chemometrics, multivariate experimentation, and modelling.
Exposure to PAT and RTRT is a plus.
Strong understanding of risk-based process control strategy, impurity management, and related regulatory expectations.
Excellent communication, stakeholder management, and collaboration skills.
Ability to work independently and across organizational boundaries.
Professional English is required; understanding of Dutch is preferred.
This is a high-impact contractor position in a technically challenging QC environment where you will help strengthen analytical capability, improve compliance, and support the lab’s evolution.
Location: Geel area.
Function: QC / Analytical Excellence & Compliance.
Type: Contractor.
Start: As soon as possible.