Quality technician (medical devices)

Assure the training and qualification of all the company’s employees:
- Defining a corporative strategy for qualification, requalification, initial and ongoing training of the company’s employees;
 - Elaboration and implementation of qualification procedures within the company;
- Defining a Training plan for every new employee and assuring its accomplishment; 
- Management of the Training and People modules of the Quality Management Software;
- Qualification in aseptic gowning technique management;
- Aseptic behaviour and practices training and monitoring
- Visual and semi-automatic inspection of injectable products qualification management;
- Participation in internal and external audits;
- Participation in the implementation of corrective actions and improvement opportunities resulting from audits;
- Managing access controls to restricted areas according to the personnel’s qualifications;
- Participation in FATs and SATs for new machines and equipment;
- Elaboration and revision of SOPs and assurance of its implementation.

Activities/responsibilities concerned with the management of an injectable penicillin’s production plant (aseptic filling and packaging lines), namely:
- Elaboration of daily and weekly production plans and assessment of its accomplishment, while developing and implementing adequate work methods and strategies;
- Identifying improvement opportunities in view of the optimization of the department;
- Controlling the levels of efficiency and quality of production; 
- Allocating and managing human resources necessary to each production line;
- Reviewing of batch records and all GMP relevant production documentation;
- Processing of batch records on ERP SAP system;
- Continuous improvement and identification of risk;
- Elaboration and reviewing of production Norms;
- Participation in internal and external audits;
- Participation in the implementation of corrective actions and improvement opportunities resulting from audits;
- Participation in FATs and SATs for new machines and equipment;
- Elaboration and revision of SOPs and assurance of its implementation;
- Initial and ongoing training of production operators;
- Participation in the recruitment and selection process of personnel for the department.