Quality Readiness Engineer - GMP Compliance & Startup

Pauwels Consulting; Geel; In loco; EUR 55.000 - 90.000; Tempo pieno

Descrizione del lavoro

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.

Competenze

• 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.

Mansioni

• 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.

Conoscenze

Quality Assurance

GMP compliance

Regulatory readiness

Quality risk assessment

Formazione

Bachelor's degree in Life Sciences/Engineering/Quality

Descrizione del lavoro

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.