EMPREGO PRODUCT ASSURANCE AND SAFETY LOURES, LISBOA

Approves iops, process master documentation and product specifications as required and appropriate... to prepare for and support internal and external site audits...

Prepare for and support internal and external site audits and inspections, conducting regular reviews and periodically following-up action plans as necessary...

Monitor progress and follow-up corrective and preventative actions... issue and follow-up change controls... knowledge on hplc and gc, and familiarity with empower...

Creation, investigation and evaluation of capas, incidents and deviations... advanced training and experience of gmp and ich guidelines standards (mandatory)...

Creation, investigation and evaluation of capas, incidents and deviations... training and experience of gmp and ich guidelines standards (desirable)...

Prepare quality and/or regulatory systems and tools related documentation and training... evaluates, advises and provides services and technical support, internally...

Strong understanding and knowledge of quality, engineering (applied to processes and hvac systems), cgmp, ich and iso guidelines, risk assessment applied to qualification...

Technical understanding of gmp practices, analytical theory and techniques - clear and open communication skills (written and verbal)... ensure appropriate communication...

Performs qualitative and quantitative analyses of compounds, including drug substances, drug product intermediates and drug product... promotes the scientific excellence...