PMO - Facility Design Compliance

Il y a 3 semaines

Walloon Region, WAL, Belgique Akkodis Temps plein

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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. 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: www.akkodis.com JOIN OUR TEAM AS A: PMO
- Facility Design Compliance Your

responsibilities:
As a Facility Design Compliance & Coordination Specialist, you will be embedded within the quality and engineering team of one of our key pharmaceutical clients in Belgium, supporting a large-scale Facility Design compliance and remediation programme across multiple manufacturing units on site. This is not a technical SME role, the technical ownership remains with the existing Facility Design expert. You will focus on coordination, follow-up, reporting and stakeholder management, ensuring the programme stays on track and that remediation actions are clearly documented, monitored and escalated where needed. Compliance assessment support �
� Coordinate with Manufacturing Unit (MU) SPOCs to review Facility Design requirements and confirm compliance or non-compliance against GQP/DGQP and Engineering Standards �
� Support risk assessments for identified gaps, helping determine risk criticality (Low / Medium / High) �
� Define and follow up on remediation actions and timelines, ensuring consistency across all Manufacturing Units Risk assessment �
� Review and update existing Facility Risk Assessments across 14+ Manufacturing Units �
� Perform periodic reviews and follow up on open actions �
� Support MU SPOCs in risk assessment and remediation planning, harmonising the treatment of similar risks across units Remediation follow-up and project coordination �
� Proactively follow up on open remediation actions with MU SPOCs �
� Challenge delays, identify blockers and escalate topics requiring management decisions �
� Prepare monthly status updates and governance material for sponsor meetings, SteerCo and the Belgium Quality Council Inspection readiness �
� Maintain a monthly Facility Design inspection-readiness package covering compliance status, open gaps, risks, remediation actions and timelines; ready for use in corporate inspections or interactions with health authorities SOP / documentation �
� Support the update of the Belgian Facility Design SOP to incorporate new GQP requirements, Engineering Standard requirements, local implementation needs and associated training

Your profile
�
� Medior profile with 3 to 7 years of relevant experience in a pharmaceutical or regulated manufacturing environment �
� Good understanding of Facility Design requirements and GxP regulations �
� Experience in risk assessment and gap remediation in a GMP context �
� Strong project coordination and action-plan management skills �
� Excellent stakeholder management; comfortable working with multiple SPOCs who are often busy and multi-tasking �
� Strong reporting and governance skills; able to prepare clear, structured material for senior stakeholders �
� Proactive, structured and able to work autonomously while supporting a technical expert �
� Fluent in French (day-to-day interactions on site) and English (documentation and deliverables) Our offer: As an Akkodis consultant, you will be: �
� Embedded within a leading pharmaceutical manufacturing site in Belgium on a strategic compliance programme �
� Supported in your career by your dedicated Akkodis Manager �
� Actor of your own training plan and professional development �
� Member of a dynamic and collaborative community of engineers and consultants �
� Benefiting from a permanent contract �
� Benefiting from a competitive salary package including several extra-legal benefits

PMO - Facility Design Compliance

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