Responsibilities

• End‑to‑End Compliance & Issue Resolution:
  Lead and drive resolution of complex GMP quality notifications (QNs), investigations, impact assessments, and CAPAs within area of responsibility, ensuring timely and high-quality closure.
  Apply risk‑based thinking and sound GMP judgment to analyze and resolve non‑standard issues, escalating when required.
  Support and contribute to robust root cause analysis and sustainable CAPA definition.
• Change & Risk Management:
  Manage and support GMP product‑related change controls and risk records, ensuring compliant and efficient execution.
  Apply quality risk management principles to manufacturing, technical, and facility topics.
  Provide input into risk assessments and change strategies.
• Operational Support & Decision Enablement:
  Provide first‑line compliance support for production troubleshooting, investigations, and cross‑functional alignment.
  Support...