Freelance QA Specialist/RP

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

For a customer in the Antwerp regio, we are searching for a freelance QA Specialist / Responsible Person (RP) to support a customer.

The successful candidate will be responsible for reviewing and verifying GMP batch manufacturing documentation, ensuring that all records are complete, accurate and compliant with applicable regulatory requirements and internal quality standards.

This is a hands‑on Quality Assurance role requiring strong experience in batch record review, GMP compliance, deviation management and quality documentation within a regulated pharmaceutical environment.

Responsibilities

• Perform detailed reviews of batch manufacturing records (BMRs) and batch packaging records (BPRs) to ensure completeness, accuracy and GMP compliance.
• Verify that manufacturing and packaging activities have been performed in accordance with approved procedures, specifications and GMP requirements.
• Identify documentation discrepancies, missing information and potential compliance issues within batch records.
• Review associated deviations, investigations, CAPAs and change controls to assess their impact on batch quality and disposition.
• Ensure batch documentation meets EU GMP requirements, internal SOPs and applicable data integrity principles.
• Collaborate with Production, Quality Control, Quality Assurance and Supply Chain teams to resolve batch documentation issues.
• Support batch disposition activities and prepare documentation for review by the Qualified Person (QP), where applicable.
• Review analytical results, certificates of analysis and supporting quality documentation as required.
• Maintain accurate, complete and audit‑ready GMP records.
• Support continuous improvement initiatives aimed at improving batch record accuracy, review efficiency and overall quality compliance.
• Participate in internal audits and regulatory inspection preparation when required.

Candidate Requirements

• Minimum 3 years of experience in Quality Assurance within a GMP‑regulated pharmaceutical or biotechnology environment.
• Proven experience reviewing GMP batch manufacturing and packaging records is essential.
• Strong understanding of EU GMP regulations, pharmaceutical quality systems and good documentation practices (GDP).
• Experience managing or reviewing deviations, CAPAs, change controls and quality investigations.
• Good knowledge of batch disposition processes and associated quality documentation.
• Familiarity with electronic batch records (eBR), electronic quality management systems (eQMS) or SAP would be advantageous.
• Excellent attention to detail and strong analytical and problem‑solving skills.
• Previous experience in a Responsible Person or senior QA capacity would be beneficial.

SENIORITY: Medior/Senior

START DATE: December/January

DURATION: 12 Months

EXTENSION: Yes

CONTRACT: Freelance

ONSITE POLICY: Flexible

HOURS PER WEEK: 40

LANGUAGES: Fluent English and Dutch

INTERVIEW PROCESS: 1 stage