Quality Operational Readiness Engineer

Pauwels Consulting; Geel; On-site; EUR 55,000 - 90,000; Full time

Job summary

Pauwels Consulting is seeking an experienced QA professional to ensure quality readiness and regulatory compliance during startup of a new production facility. You will coordinate quality activities throughout qualification phase to ensure a seamless transition from construction to operation.

Responsibilities include performing risk assessments, reviewing DQ/IQ/OQ/PQ, leading CAPA investigations, assessing change control, supporting regulatory submissions, and maintaining GMP documentation.

Qualifications

• Bachelor's degree in Life Sciences, Engineering, or Quality Management.
• 3+ years of experience in pharmaceutical or biotech Quality Assurance.
• Solid understanding of pharmaceutical manufacturing processes and technologies.
• Strong analytical and problem-solving abilities with experience in stakeholder management.
• Fluent in English.

Responsibilities

• Conduct quality risk assessments for new processes and procedures during facility startup.
• Review qualification documentation including DQ, IQ, OQ, and PQ protocols and reports.
• Manage quality event investigations including root cause analysis and CAPA implementation.
• Assess change control requests for quality impact and ensure proper documentation and approval.
• Support regulatory submission activities and preparation for pre-approval inspections (PAI).
• Maintain quality management system documentation and ensure adherence to local and international GMP requirements.
• Provide real-time quality support to project teams through routine GEMBA walks.

Skills

Quality Assurance

GMP compliance

Regulatory readiness

Quality risk assessment

Education

Bachelor's degree in Life Sciences/Engineering/Quality

Job description

Our client, a pharmaceutical organization, is seeking an experienced professional to ensure quality readiness and compliance for the startup of a new production facility. The role coordinates quality-related activities during the facility qualification phase to ensure a seamless transition from construction to operational status. This position maintains full regulatory compliance and GMP standards throughout the commissioning process.

• Conduct quality risk assessments for new processes and procedures during the facility startup.
• Review qualification documentation including DQ, IQ, OQ, and PQ protocols and reports.
• Manage quality event investigations including root cause analysis and CAPA implementation.
• Assess change control requests for quality impact and ensure proper documentation and approval.
• Support regulatory submission activities and preparation for pre-approval inspections (PAI).
• Maintain quality management system documentation and ensure adherence to local and international GMP requirements.
• Provide real-time quality support to project teams through routine GEMBA walks.

• Bachelor's degree in Life Sciences, Engineering, or Quality Management.
• You have 3+ years of experience in pharmaceutical or biotech Quality Assurance.
• You bring a solid understanding of pharmaceutical manufacturing processes and technologies.
• You possess strong analytical and problem-solving abilities with experience in stakeholder management.
• You are fluent in English.

Nice to Haves

• Understanding of risk management and change management principles and methodologies.
• Experience working with external contractors in a project-driven environment.