Debrework Mekbib

•  Lead site-wide compliance strategy as site compliance lead, ensuring strong inspection readiness and consistent results. •  Strengthened CAPA management, change control performance, QMS governance and knowledge management. •  Implemented standardized nitrosamine risk management, ensured ongoing compliance with EU and FDA expectations and built system for combination products (DDC). •  Led and supported global quality initiatives: EDMS, TrackWise and LMS, including SAP, Veeva, digital yield and d

Led overall site QA systems and compliance governance. •  Ensured audit readiness for regulatory authorities and customers. •  Strengthened supplier quality oversight and documentation processes. •  Maintained quality performance during organizational transformation.

•  Managed audits, change control, documentation and supplier qualification. •  Introduced improvements in process efficiency and system governance. •  Supported validation and qualification activities.

•  Oversaw compliance activities, audits and GMP training programs. •  Managed PQR/APR and technical documentation systems.

Responsible for internal and external auditing, documentation management, change control management, system GMP training, product annual reviews, technical agreements, annual reports for the US.

Setting up the system for managing of clinical studies according to GCP rules. Clincal studies auditing at the clinical trial sites across CEE countries.

Responsiblity for management of activities associated with registrations of human and veterinary pharmaceuticals in the territories of CEE, CIS, US, Western Europe Pharmacovigilance support, including PSUR writing and AE reporting interface, SmPC and package leaflets writing