Quality Assurance Specialist

Il y a 2 jours

Geel, Flanders, Belgique Talentmark Temps plein

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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 escalate 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.

Interested? Please get in touch via this page

Quality Assurance Specialist

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