QA Specialist, Biopharma Manufacturing & Data Integrity

Vulcain Engineering Group | Belgium; Geel; Sur place; EUR 45 000 - 51 000; Plein temps

Avantages offerts par ce poste

Company car

Fuel card

Representation fees

Insurances

Meal vouchers

Eco cheques

Sectorial bonus

Résumé du poste

Vulcain Engineering Group in Belgium seeks a QA Specialist to support GMP-compliant QA activities in a multi-product Drug Substance facility. You will review batch records, manage documentation, and ensure data integrity across manufacturing operations.

The role requires a Bachelor's or Master's in a scientific field and 2+ years in QA within regulated environments, with Dutch and English fluency. Collaboration with cross-functional teams and continuous improvement are key aspects of the job.

Qualifications

• Bachelor's or master's degree in a scientific discipline or equivalent experience.
• 2+ years in Quality Assurance in regulated environments.
• Strong knowledge of cGMP, data integrity and QA processes.

Responsabilités

• Perform QA reviews of batch records and logbooks (electronic and paper).
• Issue, control, and archive batch records and related documents.
• Review and approve SOPs, forms, and work instructions.
• Own and maintain quality documentation to GMP standards.
• Provide QA oversight for alarm management activities.
• Collaborate with Manufacturing, Engineering, Validation and cross-functional teams.
• Contribute to continuous improvement within Quality.

Connaissances

Quality Assurance

Batch record review

cGMP

Data integrity

Deviations

CAPAs

Change controls

Document management

Cross-functional collaboration

Dutch language

English language

Formation

Bachelor's degree in a scientific discipline

Master's degree in a scientific discipline

Description du poste

Vulcain Engineering Group in Belgium seeks a QA Specialist to support GMP-compliant QA activities in a multi-product Drug Substance facility. You will review batch records, manage documentation, and ensure data integrity across manufacturing operations.

The role requires a Bachelor's or Master's in a scientific field and 2+ years in QA within regulated environments, with Dutch and English fluency. Collaboration with cross-functional teams and continuous improvement are key aspects of the job.