Biotech QA Release & Documentation Specialist

Pauwels Consulting

Gent

Sur place

EUR 52 000 - 70 000

Plein temps

Il y a 8 heures

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Résumé du poste

Pauwels Consulting is seeking a Quality Assurance professional to oversee documentation compliance and batch record disposition within a biotech manufacturing setting. You will review manufacturing activity documentation in line with GDocP standards and perform batch record reviews across commercial, development, and engineering production.

In this role, you will drive improvements in batch record processes, collaborate with manufacturing teams to resolve discrepancies, and support CAPA

Qualifications

QA Release experience and cGMP compliance.
Knowledge of GDocP standards and documentation review in pharma/biotech context.
Experience reviewing paper and electronic batch records and MES.
Fluent in English; Dutch or French knowledge is a plus.

Responsabilités

Review documentation for manufacturing activity execution in accordance with GDocP.
Execute paper and electronic batch record review for commercial, development, and engineering production.
Contribute to process improvement of batch records to meet QA batch disposition deadlines.
Collaborate with manufacturing teams to resolve discrepancies related to GDocP or MES inventory.
Implement CAPA by investigating non-conformances promptly.
Maintain compliance with safety policies, quality systems, and cGMP requirements.