Quality assurance

I started working as a Quality Assurance Technician in a traditional pharmaceutical company where I supported directly the Qualified Person of the company, and where I gained experience in quality systems. Main Responsibilities:  
 
• Lot documentation review (packaging materials, from raw materials to the finished product) for subsequent approval of the Technical Department;   
• Quality Management: Control of documents, Opening and closing of corrective and preventive actions; Internal Audits; Qualification/Validation;  
• Close interaction with clients; Responses to complaints and full support to the Technical Department (Qualified Person);  
• Management of calibration and maintenance of monitoring and measurement equipment (MME) including contract negotiations with subcontractors;  • Management and control of the annual plan of stability testing and verification of the results and final reports;  
 • Reporting protocols and validation of analysis, process and cleaning validation methods; 

As a Quality Assurance Director is part of my job to monitor the results of the work of quality control, all production data and also the corresponding batch production records for a final QP approval, bearing always in mind the GMP compliance. Also to take part on the QMS periodic review and implementation of objectives. Quality assurance plays also an important role in maintenance activities, including the annual maintenance and calibration plan or work related with facilities changes.

• QMS: Training System; Calibration and maintenance of Equipment; Procedure and instructions management; OOS; Deviations, Non-conformances, CAPAs, Complaints are recorded, evaluated regarding its impact; 
• Batch Records Revision 
• Perform Self-Inspection and/or Quality Audits(Sub contracted)  that regularly evaluates the effectiveness and applicability of the QMS/ responsible for regulatory Inspections;  
• Direct contact with clients and shareholders; 
• Guarantee that the Production and Quality Control activities are clearly specified and GMP compliant; that materials and raw materials used for the manufacture and packaging of products are compliant;  
• Guarantee that the manufactured products are not dispatched before the Qualified Person has certified that each batch has been produced and controlled according with the specifications approved by the client and all other relevant regulatory requirements;  
• Ensure that records are made, manually or by instruments during manufacture, that demonstrate that all the steps required by the defined procedures were actually performed and that the quantity and quality of the product is expected and that all significant deviations are evaluated regarding its impact and investigated their causes.