GMP Batch Records Specialist

MindCapture BV

Geel

Remote

EUR 40,000 - 60,000

Full time

12 hours ago
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Benefits offered by this job

Meal vouchers
Eco vouchers
Health insurance
Group insurance
Net expense allowance
Company car with charging or fuel card

Job summary

MindCapture BV is seeking a Junior Batch Record Reviewer to support pharmaceutical manufacturing operations in Geel. You will prepare, review and verify production batch documentation, ensuring GMP/GDP compliance and close collaboration with production and quality teams on-site.

Key responsibilities include detailed batch record reviews, documentation preparation, deviation management, and ensuring complete attachments and lab results.

Qualifications

  • Experience in the pharmaceutical sector is required.
  • Strong GMP knowledge is essential.
  • Knowledge of GDP regulations is required.
  • Experience with batch record review is required.
  • Excellent attention to detail and data accuracy.
  • Fluency in Dutch (spoken and written) is essential.
  • Ability to work under strict deadlines and priorities.

Responsibilities

  • Batch Record Review: Review production and cleaning batch records for accuracy and compliance.
  • Batch Documentation Preparation: Prepare and complete batch documentation.
  • Batch Trending: Generate batch trending data and identify discrepancies.
  • Documentation Verification: Ensure attachments, lab results are present.
  • Raw Material Verification: Confirm consumption of raw materials.
  • Deviation Management: Identify, assess and initiate nonconformances.
  • Documentation Compliance: Ensure GMP/GDP compliance in documentation.
  • Batch Record Archiving: Maintain and archive batch records accurately.
  • Cross Functional Collaboration: Work with production and QA to resolve issues.

Skills

GMP Knowledge
GDP Knowledge
Batch Record Review
Documentation Accuracy
Organisational Skills
Time Management
Dutch Language Proficiency
Collaboration Skills
Pharmaceutical Industry Experience

Job description

MindCapture BV is seeking a Junior Batch Record Reviewer to support pharmaceutical manufacturing operations in Geel. You will prepare, review and verify production batch documentation, ensuring GMP/GDP compliance and close collaboration with production and quality teams on-site.

Key responsibilities include detailed batch record reviews, documentation preparation, deviation management, and ensuring complete attachments and lab results.

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