QA Specialist

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

Join our client as a QA Specialist and play a key role in maintaining top-tier quality standards! If you have a keen eye for detail and a passion for compliance, this could be your perfect opportunity.

R&D Partners is seeking a QA specialist for production plant 1 to join our client's QA Operations department. In this position, you will be responsible for quality support of the operations activities of a multi-product facility. Specifically, we are looking for someone to support a digitization project where paper manufacturing batch records are converted into electronic batch records.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

• 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
• Knowing when issues need to be escalated to a supervisor/manager

Required Skills & 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 knowledge of the English language
• €300 to €350 per day.

For more information, please contact Grant Van Schalkwyk.

By submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data - https://www.r-dpartners.com/privacy-policy/