Quality Assurance Specialist

Talentmark; Geel; Sur place; EUR 55 000 - 75 000; Plein temps

Résumé du poste

Talentmark is seeking two QA Specialists for a combined role in QA Operations and Digital Manufacturing within a pharmaceutical setting. One profile emphasizes digitalization, eBR and MES; the other focuses on day-to-day QA operations, batch record review and production support.

Responsibilities include reviewing electronic/paper batch records, eMBRs in MES (PAS-X preferred), supporting digitalization, maintaining quality docs, and ensuring cGMP compliance across clinical and commercial

Qualifications

• Master’s degree in a scientific discipline (or equivalent).
• Strong knowledge of cGMP in a regulated manufacturing environment.
• Experience in Quality Assurance and Quality processes.
• Experience with batch record review.
• Experience with electronic batch records and/or MES systems; PAS-X is a plus.
• Knowledge of data integrity within GMP.
• Experience with manufacturing/digitalization projects is a plus.
• Experience with clinical manufacturing regulations is a plus.
• Excellent attention to detail and a high level of accuracy.
• Independent and proactive working style.
• Strong communication and teamwork skills.
• Strong written communication skills in English.

Responsabilités

• Perform quality reviews of electronic and paper-based batch records, logbooks and other operational documentation.
• Review and approve Electronic Master Batch Records (eMBRs) within a MES environment, preferably PAS-X.
• Support the transition from paper-based to electronic batch records and other manufacturing digitalization initiatives.
• Prepare, review and maintain Quality documentation, including project documentation, quality plans, SOPs, forms and risk assessments.
• Contribute to Deviation Prevention (DPP) and Human Error Prevention (HEP) initiatives.
• Ensure compliance with cGMP, SOPs, global standards, applicable regulations and product registrations for clinical and commercial manufacturing.
• Provide quality oversight within manufacturing operations, including operational documentation and alarm management.
• Collaborate with various departments across Quality, Manufacturing and project teams.
• Identify quality and compliance issues and escalate them appropriately when required.
• Contribute to continuous improvement of quality and manufacturing processes.

Formation

Master’s degree in a scientific discipline

Outils

PAS-X

Electronic Batch Records (eBR)

MES systems

Data integrity

Description du poste

QA Specialist – QA Operations & Digital Manufacturing

We are looking for two QA profiles within the same QA Operations environment for a pharmaceutical company: one with a stronger focus on digitalization, electronic batch records (eBR) and MES, and one with a stronger focus on day-to-day QA Operations, batch record review and production support. The profile below provides a combined summary of both positions, with the key differences reflected in the responsibilities and requirements.

Your Responsibilities

• Perform quality reviews of electronic and paper-based batch records, logbooks and other operational documentation.
• Review and approve Electronic Master Batch Records (eMBRs) within a MES environment, preferably PAS-X.
• Support the transition from paper-based to electronic batch records and other manufacturing digitalization initiatives.
• Prepare, review and maintain Quality documentation, including project documentation, quality plans, SOPs, forms and risk assessments.
• Contribute to Deviation Prevention (DPP) and Human Error Prevention (HEP) initiatives.
• Ensure compliance with cGMP, SOPs, global standards, applicable regulations and product registrations for clinical and commercial manufacturing.
• Provide quality oversight within manufacturing operations, including operational documentation and alarm management.
• Collaborate with various departments across Quality, Manufacturing and project teams.
• Identify quality and compliance issues and escalated them appropriately when required.
• Contribute to continuous improvement of quality and manufacturing processes.

What We Are Looking For

• A Master’s degree in a scientific discipline, or equivalent experience.
• Strong knowledge of and experience with cGMP in a regulated manufacturing environment.
• Experience in Quality Assurance and Quality processes.
• Experience with batch record review.
• Experience with electronic batch records and/or MES systems; experience with PAS-X is a plus.
• Knowledge of data integrity within a GMP environment.
• Experience with manufacturing and/or digitalization projects is a plus.
• Experience with clinical manufacturing and related regulations is a plus.
• Excellent attention to detail and a high level of accuracy.
• Independent and proactive working style.
• Strong communication and teamwork skills.
• Strong written communication skills in English.

What We Offer

You will join a professional, internationally oriented manufacturing environment where quality, compliance and digitalization are key priorities. The role offers the opportunity to contribute both to day-to-day QA Operations and to important digitalization initiatives within manufacturing.