QA Operational Readiness Officer

Who we are

Akkodis is a global digital engineering and smart industry leader, bringing together talent and technology to engineer a smarter future. With more than 50,000 experts worldwide and over 1,000 in Belgium, we support companies across industries in innovation, digital transformation and R&D; from consulting and talent solutions to end-to-end project delivery. Driven by passion, expertise and impact, we make incredible happen.

In Belgium, we operate through 7 dedicated practices, where our consultants receive the technical guidance, coaching and support they need to grow and fully unlock their potential. We believe in empowering our talent by providing the right expertise, knowledge-sharing and development opportunities to help them thrive. Our practices: Product & System Development, Validation & Verification, Manufacturing & Operations, Cloud Infrastructures & Security, Data Analytics & Artificial Intelligence, Digital & Software and Wireless & Connectivity.

Akkodis is part of the Adecco Group. You can find more information on our website :

Mission

In this position, you act as the designated Change Control Coordinator for the Plant 3 construction project, with responsibility for technical quality oversight of facility construction, modifications, and utility upgrades. You ensure a controlled transition from construction phases to operational status while maintaining full GMP compliance throughout the transformation process. The role combines operational quality activities, change control management, risk assessment, and operational readiness to secure compliant, robust, and sustainable manufacturing operations.

Your responsibilities

• Lead change control activities as the designated Change Control Coordinator for the Plant 3 construction project, ensuring structured evaluation and implementation of all changes.
• Review, assess, and coordinate all change control requests impacting quality, facilities, utilities, and production systems, maintaining clear traceability and compliance with GMP expectations.
• Ensure proper documentation, risk assessment, and approval workflows for facility modifications and production area modifications and expansions, including related utility system upgrades.
• Oversee utility system upgrades for HVAC, compressed air, steam, and water systems, reviewing engineering drawings, specifications, and technical documentation for quality impact.
• Interface with external contractor, project team, and routine organisation regarding change controls, ensuring alignment on quality requirements and project timelines.
• Provide real-time quality support to project teams and contractors, including on-site guidance during construction and reconstruction activities in active areas.
• Maintain and update quality management system documentation and review project documentation, such as Master batch records, preventive maintenance programs, P&IDs, and architectural lay-outs.
• Escalate critical quality issues to management in a timely manner and conduct routine GEMBA walks in active construction/reconstruction areas to observe practices and identify risks.
• Follow-up on quality aspects of facility qualification, including DQ, IQ, OQ, and PQ protocols, and coordinate with engineering teams on quality-critical facility systems such as HVAC, water systems, and utilities.
• Support facility design qualification and ensure compliance with applicable regulatory requirements for pharmaceutical and biotech manufacturing operations.
• Conduct comprehensive quality risk assessments for new processes and procedures, identifying potential quality impacts from construction activities on ongoing operations and developing mitigation strategies.
• Monitor risk indicators, implement preventive measures, and assess the impact of facility changes on existing validated systems and processes to maintain their validated state.

What skills do you bring to the table?

• Bachelor’s degree in Engineering (Chemical, Mechanical, Civil), Life Sciences or a related technical field.
• 3+ years of experience in pharmaceutical/biotech industry, with direct exposure to GMP environments and quality systems in manufacturing or project settings.
• Proven experience in change control management and coordination, ideally involving facility, utility, or production system modifications within regulated environments.
• Strong knowledge of GMP regulations and pharmaceutical quality systems, enabling effective oversight of construction, qualification, and operational readiness activities.
• Understanding of facility systems including HVAC, water systems, compressed air, steam, and utilities, and their criticality for maintaining controlled manufacturing conditions.
• Understanding of process validation and facility validation/qualification principles, including the application of DQ, IQ, OQ, and PQ in facility projects.
• Strong analytical and problem-solving abilities with technical aptitude, allowing systematic assessment of risks, quality impacts, and mitigation options.
• Effective communication and stakeholder management skills to work with cross-functional teams, contractors, project teams, and external vendors in a structured manner.
• Attention to detail with strategic thinking capability, balancing day-to-day quality oversight with long-term operational readiness and compliance objectives.
• Ability to work with cross-functional teams, contractors, and external vendors in complex project environments while maintaining focus on quality and GMP compliance.
• Fluency in both Dutch and English

Our recruitment process

Stage 1: Initial telephone interview (15 min) with @Bo, Talent Acquisition Specialist.

Step 2: Interview (60 min) with a Business Manager.

Step 3: Interview (60 min) with the client.

Interested? Apply now or send an e-mail to bo.schoonjans@akkodis.com so we can get in touch!