Quality assurance specialist (MBR verification) - 12 months
Location: Ghent (on-site)
Contract end date: 31/12/2027
Overview
We are seeking a Quality Assurance professional to oversee quality deliverables related to electronic Master Batch Records and Manufacturing Execution Systems.
The successful candidate will provide QA oversight throughout project execution, ensuring compliance with GMP, data integrity requirements, and internal quality standards while collaborating with manufacturing, IT, validation, and project teams.
Key Responsibilities
- Provide QA oversight for MES-related projects and routine operational activities.
- Review electronic Master Batch Record (eMBR) verification documentation.
- Assess Design Specifications, verification strategies, protocols, and associated testing documentation.
- Review executed verification documentation and ensure appropriate issue resolution.
- Evaluate traceability matrices, qualification documentation, quality plans, project reports, and go-live packages.
- Support quality and data integrity reviews for PAS-X master data and electronic batch records.
- Verify compliance with GMP regulations, quality standards, and company procedures.
- Identify risks, deviations, observations, and corrective actions, ensuring appropriate follow-up.
- Maintain inspection-ready documentation.
- Build effective working relationships across QA, Operations, Manufacturing, IT, and Project teams.
- Contribute to process improvements and continuous quality initiatives.
Requirements
- Bachelor's or Master's degree in Life Sciences, Pharmacy, Engineering, Bioengineering, or related discipline.
- Minimum 3 years of pharmaceutical industry experience, ideally within GMP manufacturing environments.
- Strong knowledge of GMP regulations and quality systems.
- Experience working with Master Batch Records.
- Previous involvement in QA review activities for validation, qualification, verification, or testing documentation.
- MES experience is strongly preferred.
- PAS-X experience is highly advantageous.
- Strong analytical and problem-solving abilities.
- Excellent communication and stakeholder management skills.
- Ability to operate independently within fast-paced, cross-functional environments.
Ideal Candidate Profile
The ideal candidate is a GMP Quality Assurance professional with experience reviewing validation, verification, or qualification documentation within pharmaceutical manufacturing. They have a solid understanding of Master Batch Records and electronic manufacturing systems, ideally PAS-X. They are detail-oriented, comfortable working with technical documentation, and capable of partnering with Operations, QA, IT, and Engineering teams to support compliant digital manufacturing solutions.
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