Maintenance of the Quality Management System (QMS) and application of the Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) for medicinal gases and Medical Devices;
QMS, GMP, GDP and Medical Devices training to all personnel involved in medicinal product and medical devices activities;
Cooperate in any decision to quarantine or dispose of returned, rejected, recalled or falsified products;
Evaluate the impact of any change that could impact the QMS, GMP, GDP or Medical Devices;
Process monitoring and prepare Quality Control Reports and Product Quality Reviews (PQR);
Equipment Qualification and Process Validation, Protocols, Risk Analysis and Validation Reports;
Ensure that internal and external audits (in the scope of QMS, GMP, GDP and Medical Devices manufacturing and - - - Distribution Devices are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place;
Ensure that self-inspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place;
Ensure that corrective/preventive actions, consequence of deviations, non-conformities, recalls, out of specification results, complains, pharmacovigilance, audits or inspections, are fulfilled and registered in conformity with QMS, GMP, GDP and Medical Devices compliance monitoring and follow up the entire recall process by making all the records and preparing a final report of the whole process;
Support in Marketing Authorization process maintenance and ensure regulatory compliance with regards to medicinal products, medical installations and authorizations and be the contact person with National Health Authority;
Monitor applicable legislation and evaluate the impact of the changes, implementing any action that is identified as necessary to ensure regulatory compliance;
Act as Local Vigilance Officer following local vigilance regulations and implementing global vigilance standards.
