moran dvora

* Managed six teams: wet chemistry, GC, HPLC, packaging materials. * Managed release of raw materials and packaging for production. * Managed section's work plan according to the plant's and customers’ requirements. * Lead laboratory investigations. * Preparation and escorted audits: FDA, EMEA, Israeli Ministry of Health and customers.

* Lead the department responsible for Quality Compliance: Supplier qualification, GDP (Good Distribution Practice), internal and external audits and other quality projects. * Managed a team responsible for QA Laboratories activities. * Performing internal audit and external audits for manufacturers and service providers. * Preparation and escorting regulatory and customers’ audits.

* Guided and approved laboratory investigations according to SOPs and regulatory requirements. * Performed and lead incoming materials deviations reports. * Performed annual laboratory quality audits and supported regulatory audit preparations. * Reviewed and approved laboratory documents.

* Training of the methodology of Operational Excellence for local change agents. * Escort and support change agents in QC and QA departments. * Coordination and knowledge sharing with parallel global teams.