Quality assurance specialist

Responsible to schedule, ensure the fulfillment and give support to the auditors of Internal Audits;
Execute all actions related with audits (prepare the audit; provide support during the audit, follow up with the relevant the response to the audit observations, prepare the audit response to the Clients, Authorities (FDA, Infarmed, etc) and Consultants);
Follow CAPA implementations related with Internal, consultants, clients and Authorities Audits (FDA, Infarmed, etc);	 	
Perform preliminary GAP analysis evaluation for 483s (issued by FDA) and follow up with the different departments the answer to 483s GAP analysis;
Maintenance of department SOPs and documentation;
Prepare communications and requests to Regulatory Authorities;
Ensure the current GMP guidelines are available in the system

 	Document management and Corrective actions (CAPA);
 	Quality inspections and audits;
 	Investigation reports concerning complaints;
 	Physical and Chemical analysis;
 	Maintenance and calibration of equipment.

 	Quality control and development of the chemical processes involved in the activity sector;
 	Development of assays for new articles

A course of recognized quality and accredited by the Ministry of Science and Higher Education.