QA Operational Readiness Officer

Our client, a leading life sciences organization, is seeking a QA Operational Readiness Officer to support the start-up of a new production facility. The role focuses on providing comprehensive quality documentation review and hands-on operational support during the facility qualification and start-up phase.

• Review and approve quality documentation including preventive maintenance plans, SOPs, and qualification protocols (DQ, IQ, OQ, PQ).
• Author risk assessments for new processes, equipment, and procedural changes using structured methodologies.
• Perform gap analyses between draft documents and GMP requirements or regulatory expectations.
• Provide quality support on the shop floor during manufacturing and engineering qualification activities and first production runs.
• Assist in quality event investigations, including deviations, non-conformances, and out-of-specification results.
• Manage change control activities and update QMS documentation in line with site procedures.

• You have a Bachelor’s degree in Life Sciences, Engineering, or Quality Management.
• You bring 1+ years of experience in pharmaceutical or biotech quality assurance or a relevant internship in a GMP environment.
• You possess a foundational understanding of risk management principles and technical document authoring.
• You have strong attention to detail and the ability to identify gaps or inconsistencies in documentation.
• You’re a proactive communicator who is comfortable supporting cross-functional teams in a fast-paced environment.
• You are fluent in English.

Nice to Haves

• Familiarity with GMP documentation principles and quality systems.
• Experience with FMEA, HACCP, or eMBR templates.

• 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.