QA Coordinator

Pauwels Consulting; Geel; Sur place; EUR 60 000 - 80 000; Plein temps

Résumé du poste

Pauwels Consulting, on behalf of a leading pharmaceutical organization, seeks an MBR Coordinator to support the startup of a new production facility. The role focuses on quality readiness, operational excellence, and regulatory compliance during commissioning to transition to operation with meticulous batch record oversight and GMP adherence.

You will review and align eMBRs with GMP and site procedures, implement process improvements into batch record templates, and collaborate with

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, Quality Management, or related field.
• 3+ years of experience in pharmaceutical or biotech quality assurance.
• Experience in MBR authoring, batch record review, and compliance management.
• Strong GMP understanding and pharmaceutical manufacturing technologies.

Responsabilités

• Coordinate the review and approval of electronic Master Batch Records (eMBRs) per GMP.
• Incorporate lessons learned and improve batch record templates for compliance.
• Collaborate with manufacturing and process development to reflect validated processes.
• Support quality review of batch records during PQ and PPQ qualification runs.
• Manage document lifecycle and version control in the QMS.
• Conduct GEMBA walks to ensure shop-floor practices follow instructions.

Connaissances

Quality Assurance

GMP Knowledge

Stakeholder Management

Attention to Detail

Formation

Bachelor’s degree in Life Sciences

Description du poste

Our client, a leading pharmaceutical organization, is seeking a MBR Coordinator to support the startup of a new production facility. The project focuses on ensuring quality readiness, operational excellence, and regulatory compliance during the commissioning phase. This role is essential for managing the transition to operational status through meticulous batch record oversight and GMP adherence.

Responsibilities

• Coordinate the review and approval of electronic Master Batch Records (eMBRs) ensuring alignment with GMP requirements and local procedures.
• Integrate site lessons learned and process improvements into new batch record templates to enhance compliance.
• Collaborate with manufacturing and process development teams to ensure MBR content reflects validated processes and specifications.
• Support the quality review of executed batch records during PQ and PPQ qualification runs.
• Manage the document lifecycle and version control of quality documentation within the QMS.
• Conduct routine GEMBA walks to validate that shop-floor practices align with documented instructions.
• Perform quality risk assessments for new processes and review qualification documentation to support project timelines.

Requirements

• Bachelor’s degree in Life Sciences, Engineering, Quality Management, or a related field.
• You have 3+ years of experience in pharmaceutical or biotech quality assurance.
• You possess experience in quality assurance including MBR authoring, batch record review, and compliance management.
• You bring a strong understanding of GMP standards and pharmaceutical manufacturing technologies.
• You're recognized for your analytical abilities, attention to detail, and effective stakeholder management skills.

Nice to Haves

• Experience managing priorities within a fast-paced project environment.
• Willingness to collaborate with cross-functional teams and external contractors.