QA Specialist - Digital Batch Records & Compliance

R&D Partners; Geel; Sur place; EUR 55 000 - 65 000; Plein temps

Résumé du poste

R&D Partners is seeking a QA Specialist to support production plant QA Operations and a digitization project converting paper batch records to electronic records.

The role requires a Master’s degree in a scientific field, knowledge of cGMP, experience with electronic batch records (MES Pas-X), and strong English. The ideal candidate is detail‑oriented, independent, and a good team player.

Qualifications

• Master’s degree in a scientific field or equivalent through experience.
• Knowledge of cGMP in a regulated environment.
• Experience with electronic batch records and digital systems.
• Knowledge of Quality Processes and Quality Assurance.
• Excellent accuracy and attention to detail.
• Independent and responsible with strong teamwork and communication.
• Good knowledge of English.

Responsabilités

• Drafting and reviewing quality documentation within the project framework.
• Reviewing and approving electronic master batch records in MES Pas-X.
• Drafting and reviewing project documentation with a view to deviation prevention and human error prevention.
• Ensuring compliance with SOPs, global standards, regulations, and product registrations.
• Escalating issues to a supervisor/manager when needed.

Connaissances

Attention to detail

Communication

Independence

Team player

English language

Formation

Master's degree in a scientific field

Outils

MES Pas-X

electronic batch records

Description du poste

R&D Partners is seeking a QA Specialist to support production plant QA Operations and a digitization project converting paper batch records to electronic records.

The role requires a Master’s degree in a scientific field, knowledge of cGMP, experience with electronic batch records (MES Pas-X), and strong English. The ideal candidate is detail‑oriented, independent, and a good team player.