Support and coordinate audit and inspection activities, ensuring timely closure of commitments and compliant documentation within the Quality Management System (QMS).
Organize and facilitate site governance meetings, including agenda preparation, stakeholder coordination, meeting documentation, and follow-up of action items.
Assist in the execution and tracking of the Self-Inspection Program to maintain inspection readiness and drive continuous compliance improvements.
Provide operational support for QMS processes such as deviations, CAPAs, change controls, training management, and quality risk management.
Maintain accurate quality documentation, KPIs, trackers, dashboards, and metrics while identifying opportunities to improve QMS efficiency and compliance visibility.
Profile
Bachelor's degree in Life Sciences, Biotechnology, Pharmacy, Engineering, Quality Management, or a related discipline.
Initial experience in Quality Assurance, Quality Systems, GMP-regulated manufacturing, or the pharmaceutical/biotech industry is preferred.
Knowledge of Quality Management Systems, GMP requirements, audits, inspections, CAPAs, deviations, and change control processes.
Strong organizational, communication, and stakeholder management skills, with the ability to collaborate effectively across cross-functional teams.
Fluent in English (written and spoken), with a proactive, self-driven mindset and the ability to prioritize multiple activities in a dynamic environment.