Seval Avdzha

For a Graphic Design Company, managing few long term projects and their ongoing inquiries - receiving, setting up, distribution and scheduling of tasks, keeping track of the progress, deadlines, problem solving, delivery, feedback. Main point of customer contact.

Project Management for B2B companies, mainly Scandinavian, related to translations of business documents and busness text. Receiving, preparing setting up the projects, including finding the right linguists for the specific tasks, managing deadlines, keeping track of progress, handling issues related to delays and ensuring on-time delivery. Juggling among multiple translation software and different client requirements simultaneously.

Facilitated clinical trial initiation meetings among hospital's departments and the company's clinical trials pipeline. Familiarized medical personnel with studies requirements, steps and necessary actions at each phase. Assisted with the collection and completion of mandatory data and documentation. Responsible for the correct upload of information in designated software, as well as archive management of the studies.

• Managed current & initiated new stability & transportation studies for production of medical devices;
• Retrieved product samples into/from the stability chambers for planned testing, coordinated sample shipments and test procedures with internal labs, external test suppliers and manufacturing sites;
• Reviewed test results, assisted with investigation and closure of non-conformities, participated in CAPA analyses;
• Issued Quality Protocols and Reports and ensured studies' database is updated and compliant with various regulatory requirements at all times.

• Interpretation of ISO 9001:2015 standard's requirements to build an internal Quality Management System / Framework;
• Strategic and operational process development - design and documentation of quality policies, standard work procedures, work instructions, guidelines and templates;
• Data collection, analyses, reporting, as well as design of operational KPIs in Ms Excel; record and archive management;
• Support within the preparation and execution of internal and external audits for the certification;
• Training material preparation and training of employees over the later certified QMS;
• Process database, process improvement updates and document versioning responsible;
• Customer satisfaction process development, point of contact feedback management.