Quality technician (medical devices)

- Knowledge of Eudralex, ICH, ISO and GMP guidelines
- Regulatory affairs and quality systems
- Active substances, raw materials and final products quality and purity in accordance with established specifications, regulatory guidance and company polices and that documentation is accessible and ensures traceability/accountability
- Chemical processes production of veterinary products
- Identify the critical process parameters during the manufacturing process
- Responsible for the release of the product batches to the market
- Conduct regular inspections (internal and external audits) by official/regulated entities
- Ensure the execution of GMP training to staff
- Writing, revision of SOP’s, quality related reports (e.g. Product Quality Review) and Corrective and Preventive action (CAPA) plans
- Approve qualification and validation documentation (e.g. protocols and reports)
- Oversight of the trends within production (i.e. in-process controls, finished product specifications, change controls, CAPAs, deviations, non-conformances, complaints and recalls) to manage risk and improvements
- Perform risk assessments analysis (e.g. FMEA)

- Experience in coordinating a team for the development of new agrochemical products based on fungicides, insecticides and herbicides active substances and organize all the current projects and laboratory documentation and facilities (e.g., state-of-art, project management and optimization, results analysis, write SOPs and reports)
- Selection of suitable excipients for product composition
- Products stability taking into account ICH Topic Q1A
- Experience in working under a certified Quality Management System following ISO 17025
- Process safety reviews and chemical reaction hazard identification of agrochemical processes manufacturing
- Scale-up management
- Identifying opportunities for continuous improvement in R&D focusing on quality, efficiency and control of costs

- Development of hybrid drug delivery systems for pulmonary route for treatment of pulmonary disease
- Spray-drying techniques
- Full physicochemical and aerodynamic characterization of micro/nano particles
- Molecular biology: bacteria transformation and plasmid purification, electrophoresis
- Cyto- and Biocompatibility by in vitro cell studies and in vivo studies using rats as models