Responsibilities:
- Moderate daily NC/CAPA governance meetings and drive structured governancediscussions
- Coordinate cross-functional stakeholders across Operations, MSAT, QA, Engineering,GET, and support functions
- Challenge teams where governance process, timelines, escalation discipline, oroperational follow-through are not aligned
- Drive governance discipline, escalation follow-up, action tracking, and operationalaccountability activities
- Monitor stakeholder participation, governance meeting adherence, and operationalengagement
- Trend and analyze daily NC/CAPA activity, recurrence patterns, aging metrics, andescalation risks
- Facilitate RCA discussions and RCPS workshops for complex investigations and1recurring operational issues
- Facilitate recurring RCPS exercise coaching sessions for operational teams
- Support Lean problem-solving methodologies including 5 Why, Fishbone, Fault TreeAnalysis, DMAIC, Pareto, Kaizen...Etc
- Support governance reporting, dashboard visibility, KPI reviews, and operational reviewactivities
- Perform hands-on operational engagement including shopfloor interaction, coaching,observation, and governance follow-up
- Ensure governance execution aligns with GMP requirements, SOPs, and complianceexpectations
- Support operational teams in improving investigation quality and CAPA effectiveness
- Drive continuous improvement initiatives related to governance maturity and operationalexcellence
- Support audit readiness activities and governance documentation reviews
- Manage investigation ownership and approval accountability for NC/CAPA records
- Complete additional governance and operational support activities assigned bySupervisor / ManagerQualifications Required:
- Bachelor's degree in engineering, Life Sciences, or related technical discipline
- 8–10 years of experience in NC/CAPA governance, Operational Excellence, or GMP-regulated operations
- Hands-on Pharma / GMP operational experience
- Experience moderating NC/CAPA governance meetings and cross-functional operationalforums
- Experience in RCA facilitation and RCPS coaching methodologies
- Lean Green Belt / Black Belt or RCPS Certification preferred
- Strong understanding of GMP, Quality Systems, and NC/CAPA lifecycle management
- Strong communication, stakeholder coordination, and escalation management capability
- Experience managing high-volume operational governance environments
- Dutch-speaking capability (Mandatory)Skills:
- Strong governance, moderation and facilitation capability
- RCA / RCPS Methodology & Coaching
- CAPA / 8D Methodology
- Escalation Management & Operational Follow-Up
- KPI Monitoring, Trending & Governance Reporting
- NC/CAPA Lifecycle Management
- Cross-Functional Stakeholder Coordination
- Lean Problem-Solving Methodologies
- GMP & Quality Systems Knowledge
- Continuous Improvement & Operational Excellence2
- Dashboard & Reporting Tools (Power BI, Tabluea..Etc)
- Truvault NC/CAPA Documentation Systems
- PLM / Governance Reporting Tools
- Strong communication, analytical, and problem-solving skills
- Proficient in MS Office (Word, Excel, PowerPoint, etc.)