QA Operations Specialist, GMP & Data Integrity (Biopharma)

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

Avantages offerts par ce poste

Company car and fuel card

Meal vouchers

Insurance coverage

Eco cheques

Sectorial bonus

Résumé du poste

Vulcain Engineering Group | Belgium is seeking a QA Specialist to join a leading biopharmaceutical manufacturing environment. You will support Quality Assurance activities within a multiproduct Drug Substance facility, ensuring GMP compliance and data integrity across manufacturing operations.

You will review batch records, manage quality documentation, and collaborate with cross-functional teams to drive continuous improvement in quality processes and documentation management.

Qualifications

• Bachelor's or Master's degree in a scientific discipline or equivalent experience in a regulated setting is required.
• 2+ years of Quality Assurance experience in pharmaceutical, biotechnology, life sciences or other highly regulated environments.
• Strong knowledge of cGMP requirements, quality systems and Data Integrity principles.
• Experience with batch record review and GMP documentation management.
• Familiarity with deviations, CAPAs, change controls and document management is a plus.
• Team-oriented professional capable of working in a multidisciplinary environment.
• Fluent in Dutch and English.

Responsabilités

• Perform quality reviews of batch records and logbooks in electronic and paper formats.
• Manage issuance, control and archiving of batch records, logbooks and other quality documents.
• Review and approve operational documents requiring QA oversight, including SOPs, forms and work instructions.
• Own and maintain quality documentation, ensuring GMP compliance.
• Provide QA oversight and support related to alarm management activities.
• Ensure compliance with GMP regulations, quality procedures and data integrity requirements.
• Collaborate with Manufacturing, Engineering, Validation and other cross-functional teams to support operational excellence.
• Contribute to continuous improvement initiatives within Quality.

Connaissances

Quality Assurance

cGMP

Data Integrity

Batch Records

Deviations

CAPAs

Change Controls

Document Management

Team Collaboration

Dutch & English

Formation

Bachelor's or Master's degree in a scientific discipline

Description du poste

Vulcain Engineering Group | Belgium is seeking a QA Specialist to join a leading biopharmaceutical manufacturing environment. You will support Quality Assurance activities within a multiproduct Drug Substance facility, ensuring GMP compliance and data integrity across manufacturing operations.

You will review batch records, manage quality documentation, and collaborate with cross-functional teams to drive continuous improvement in quality processes and documentation management.