QA Specialist: Digital Batch Records & Compliance

R Dpartners

Limburg

Sur place

EUR 55 000 - 65 000

Plein temps

14 jours+

Générateur de candidature

Une candidature sur mesure pour ce poste — un CV personnalisé et une lettre de motivation qui correspondent directement à l’offre.

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Résumé du poste

R&D Partners in Belgium is hiring a QA Specialist to support the QA Operations department at production plant 1, focusing on digitizing documentation and converting paper batch records into electronic records. You will draft and review quality documentation, review electronic master batch records in MES Pas-X, ensure compliance with SOPs, and collaborate across departments.

The role requires a Master’s in a scientific field, knowledge of cGMP, and strong English; work involves strict accuracy

Qualifications

Master’s degree in a scientific field or equivalent through experience.
Knowledge and interpretation of cGMP in a regulated environment.
Experience with electronic batch records and related digital systems.
Knowledge and experience with Quality Processes and Quality Assurance.
Excellent accuracy and eye attention to detail.
Independence and a strong sense of responsibility.
An enthusiastic team player and strong in communication.
Good writing skills.
Good knowledge of the English language.

Responsabilités

Drafting and reviewing Quality documentation within the project framework (Project notes, Quality plans, …).
Reviewing and approving electronic master batch records in MES Pas-X.
Drafting and reviewing project documentation (e.g. procedures, risk assessments) with a view to deviation prevention (DPP) and human error prevention (HEP).
Ensuring compliance with SOPs, global standards, regulations, and product registration (filing) regarding clinical and commercial manufacturing.
Supporting cross-departmental collaboration.
Knowing when issues need to be escalated to a supervisor/manager.