Quality Control Lead
Synstack Technologies · Beerse
Job description
About the role
The Quality Control Lead will drive daily NC/CAPA governance, ensuring structured discussions, timely escalations and compliance with GMP standards. This role coordinates cross‑functional teams across Operations, MSAT, QA, Engineering, GET and support functions to improve investigation quality and CAPA effectiveness.
Key responsibilities
- Moderate daily NC/CAPA governance meetings and enforce governance discipline.
- Coordinate stakeholders from multiple functions, monitor participation and adherence.
- Trend and analyze NC/CAPA activity, aging metrics and escalation risks.
- Facilitate RCA discussions and RCPS workshops for complex or recurring issues.
- Support Lean problem‑solving methods (5 Why, Fishbone, DMAIC, Kaizen, etc.).
- Maintain governance reporting, dashboards, KPI reviews and audit readiness.
- Provide hands‑on shop‑floor engagement, coaching and follow‑up.
- Manage investigation ownership and approval for NC/CAPA records.
Required profile
- Bachelor’s degree in Engineering, Life Sciences or related field.
- 8–10 years of experience in NC/CAPA governance, operational excellence or GMP‑regulated operations.
- Hands‑on pharma/GMP operational experience.
- Proven experience moderating cross‑functional governance meetings.
- Fluency in Dutch (mandatory).
Required skills
- RCA and RCPS facilitation and coaching.
- CAPA / 8D methodology.
- Lean Green Belt / Black Belt (preferred).
- GMP and Quality Systems knowledge.
- KPI monitoring, trending and governance reporting.
- Dashboard tools: Power BI, Tableau.
- Truvault NC/CAPA documentation system.
- PLM / governance reporting tools.
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Published 1 uur geleden
Expires over 1 maand
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Synstack Technologies
Beerse
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