QA Operational Readiness Officer (GMP & Validation)

Our client, a pharmaceutical organization, is seeking a Quality Operational Readiness Officer for the start-up of a new production facility. This role focuses on ensuring quality readiness and compliance during the transition from construction to operational status. The position coordinates qualification activities and maintains high GMP standards throughout the commissioning phase.

• Review quality aspects of facility qualification including DQ, IQ, OQ, and PQ protocols and reports.
• Conduct quality risk assessments and manage investigations involving root cause analysis and CAPA.
• Assess change control requests for quality impact and review preventive maintenance plans and electronic master batch records.
• Perform readiness assessments and gap analyses for quality systems and processes.
• Support preparation for pre-approval inspections (PAI) and regulatory authority visits.
• Execute routine GEMBA walks and maintain Quality Management System documentation.

• You have a Bachelor's degree in Life Sciences, Engineering, or Quality Management.
• You bring 1+ years of experience in quality assurance including CAPA, change control, and root cause analysis within the pharmaceutical or biotech industry.
• You possess familiarity with validation processes including DQ, IQ, OQ, and PQ.
• You have a basic understanding of GMP standards and pharmaceutical manufacturing technologies.
• You're proactive with strong analytical abilities and effective stakeholder management skills.

Nice to Haves

• Understanding of risk management principles and methodologies.
• Experience with electronic master batch records or GEMBA walks.

• Enjoy a competitive salary package with extra perks that recognize your talent.
• Advance your career with a clear growth path, coaching, and mentoring to support you.
• Thrive in a dynamic and supportive environment where you can truly make an impact.
• Work when and where you perform best, ensuring an optimal work-life balance.
• Choose a flexible transport solution, from a company car to a public transport subscription.
• Expand your network and enjoy unforgettable moments at exclusive events and afterworks.
• Grow your skills with external courses and our in-house Pauwels Academy.
• Work on exciting projects with industry leaders in Life Sciences, Engineering & Digital.
• Seize opportunities at every level, from a strong start to career acceleration and expert collaboration.