QA Specialist: Digitalizing Electronic Batch Records

EFOR

Geel

Sur place

EUR 65 000 - 90 000

Plein temps

Il y a 3 jours
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Résumé du poste

EFOR Group in Geel, Belgium, is seeking a QA Specialist to support Production Plant 1 on a client site under QA Operations, in a contract role running from 01/10/2026 to 30/06/2027.

You will drive quality for operations across a multiproduct facility, focusing on digitizing batch records to electronic systems, with strong cGMP compliance and collaboration across departments.

Fluency in English, a MSc in a scientific field, and experience with electronic batch records are preferred.

Qualifications

  • Master's degree in a scientific field (or equivalent experience).
  • Solid knowledge and interpretation of cGMP in a regulated environment.
  • Experience with electronic batch records and related digital systems.
  • Strong knowledge of Quality processes and Quality Assurance.
  • Excellent accuracy and attention to detail.
  • Ability to work independently with a strong sense of ownership.
  • An enthusiastic team player with strong communication skills.
  • Good writing skills.
  • Good command of English.

Responsabilités

  • Draft and review quality documentation in the context of the project (project notes, quality plans, etc.).
  • Review and approve electronic Master Batch Records in MES PAS-X.
  • Prepare and review project documentation (e.g., procedures, risk assessments) with a focus on deviation prevention (DPP) and human error prevention (HEP).
  • Ensure compliance with SOPs, global standards, regulations, and product registration/filing requirements for both clinical and commercial manufacturing.
  • Support cross-departmental collaboration across the site.
  • Recognize when issues need to be escalated to supervisor/manager.

Connaissances

Quality Assurance
cGMP Knowledge
Electronic Batch Records
Quality Processes
Attention to Detail
Independent Working
Team Player
Communication Skills
Writing Skills
English Proficiency

Formation

Master's degree in a scientific field

Outils

MES PAS-X

Description du poste

EFOR Group in Geel, Belgium, is seeking a QA Specialist to support Production Plant 1 on a client site under QA Operations, in a contract role running from 01/10/2026 to 30/06/2027.

You will drive quality for operations across a multiproduct facility, focusing on digitizing batch records to electronic systems, with strong cGMP compliance and collaboration across departments.

Fluency in English, a MSc in a scientific field, and experience with electronic batch records are preferred.

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