Coordinates and organizes activities related to laboratory testing, sampling, product transfer in the field of responsibility Quality Control, introduction of new manufacturers in the field of quality control, preparation and review of registration documentation required for file maintenance and renewal of registration, transfer of analytical methods for new products, staff training.
– Manages the work of Quality Control and implements, maintains and develop sefficient sampling and testing processes and procedures in accordance with international and national regulations and the policy of the STADA Group
– Ensuring compliance in the field of quality control (approval / rejection of packaging materials, qualification and maintenance of premises and equipment, validation) with international and national regulations for medicines and medical devices
– Provides successful inspections by national and foreign authorities and customers, as well as control of contracted laboratories and material suppliers. Sets quality control goals in line with quality management goals.
– Participates in defining Key Quality Indicators for performance assessment.
– Responsible for monitoring and reporting on QKPIs.
– Ensures that STADA quality control employees are adequately trained to perform delegated tasks and provides a system for continuous training
– Responsible for quality control investment projects
– Ensures the implementation of laboratory tests, including the assessment of documentation, in accordance with the application of the principles of Good Manufacturing Practice in an efficient manner and with optimal use of capacity.
– Participates in resolving deviations within the domain of responsibility of Quality Control.
– Manages product transfer activities in the field of Quality Control responsibilities etc.