Change Control Coordinator / Quality Operational Readiness Officer

Our client, a pharmaceutical organization, is establishing a new production facility and is seeking a specialist to provide technical quality oversight. This role ensures a seamless transition from construction phases to operational status while maintaining full compliance during the transformation process.

• Lead change control activities for the facility construction project as the designated coordinator.
• Review, assess, and coordinate change control requests impacting quality, facilities, utilities, and production systems.
• Ensure proper documentation, risk assessment, and approval workflows for facility modifications and expansions.
• Review engineering drawings, specifications, and technical documentation such as Master Batch Records and P&IDs.
• Provide real-time quality support to project teams and contractors while maintaining quality management system documentation.
• Support quality readiness plans and follow up on facility qualification protocols including DQ, IQ, OQ, and PQ.
• Conduct comprehensive quality risk assessments for new processes and procedures to identify potential quality impacts.

• Bachelor’s degree in Engineering, Life Sciences, or a related technical field.
• You have 3+ years of relevant experience in the pharmaceutical or biotech industry.
• You bring expertise in change control management and coordination within a GMP environment.
• You possess a technical understanding of facility systems including HVAC, water systems, compressed air, and steam.
• You have knowledge of process validation and facility qualification principles including DQ, IQ, OQ, and PQ.
• You're proactive with strong analytical abilities and effective stakeholder management skills.

Nice to Haves

• Experience working with external contractors and vendors on large-scale projects.
• Familiarity with architectural layouts and preventive maintenance programs.

• 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.