QA Release Specialist

Pauwels Consulting; Gent; Sur place; EUR 52 000 - 70 000; Plein temps

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.

Connaissances

Attention to detail

Stakeholder management

QA Release

GDocP standards

Outils

MES systems

Description du poste

Our client, a leading biotechnology company, is seeking specialized support for their quality assurance operations. The role involves overseeing documentation compliance and batch record disposition to ensure the highest standards of manufacturing quality.

Responsibilities

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

Requirements

• You have relevant experience in quality assurance including QA Release and cGMP compliance.
• You bring knowledge of GDocP standards and documentation review within a pharmaceutical or biotech context.
• You possess experience with both paper and electronic batch record review and MES systems.
• You're able to process complex information with high attention to detail and strong stakeholder management capabilities.
• You are fluent in English. Knowledge of Dutch or French.

Nice to Haves

• Prior experience as a Quality Assurance or Quality Control Engineer.