QA Specialist

R Dpartners; Limburg; Sur place; EUR 55 000 - 65 000; Plein temps

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.

Connaissances

cGMP knowledge

Electronic batch records

Quality Assurance

Attention to detail

Independence

Teamwork & communication

Writing skills

English language

Formation

Master's degree in a scientific field

Outils

MES Pas-X

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
• Supporting cross-departmental collaboration
• 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 writing skills
• Good knowledge of the English language

Salary

• €300 to €350 per day.