Senior EU GMP QA and Batch Records Specialist

Vivid Resourcing; Antwerpen; On-site; EUR 74,000 - 118,000; Full time

Job summary

Vivid Resourcing seeks a freelance QA Specialist / Responsible Person (RP) to support an Antwerp-based customer. The role focuses on reviewing GMP batch records, ensuring accuracy, completeness and compliance with EU GMP and internal quality standards.

The candidate will handle deviations, CAPAs, change controls and data integrity reviews, collaborating with Production, QC, QA and Supply Chain to resolve issues and support batch disposition and QP review as needed.

Qualifications

• Minimum 3 years of QA experience in GMP-regulated pharma/biotech environments.
• Proven track record reviewing GMP batch manufacturing and packaging records.
• Strong understanding of EU GMP, GDP, and quality systems.
• Experience handling deviations, CAPAs, change controls and investigations.
• Familiarity with batch disposition processes and related docs.

Responsibilities

• Perform detailed reviews of BMRs and BPRs for completeness, accuracy and GMP compliance.
• Verify manufacturing/packaging activities follow approved procedures and GMP requirements.
• Identify documentation gaps and potential compliance issues in batch records.
• Review deviations, investigations, CAPAs and change controls for impact on batch quality.
• Ensure documentation meets EU GMP, SOPs and data integrity standards.
• Collaborate with Production, QC, QA and Supply Chain to resolve issues.

Skills

GMP knowledge

GDP knowledge

Attention to detail

Analytical thinking

Documentation skills

Regulatory understanding

English proficiency

Dutch proficiency

Tools

eBR

eQMS

SAP

Job description

Vivid Resourcing seeks a freelance QA Specialist / Responsible Person (RP) to support an Antwerp-based customer. The role focuses on reviewing GMP batch records, ensuring accuracy, completeness and compliance with EU GMP and internal quality standards.

The candidate will handle deviations, CAPAs, change controls and data integrity reviews, collaborating with Production, QC, QA and Supply Chain to resolve issues and support batch disposition and QP review as needed.