EMPREGO REGULATORY AFFAIRS SAFETY AND LOURES, LISBOA

Review regulatory documentation and co-ordination of site documentation to support regulatory requirements... experience of working with regulatory affairs and a...

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

Monitor progress and follow-up corrective and preventative actions... knowledge on hplc and gc, and familiarity with empower software... execute professional activities...

Prepare quality and/or regulatory systems and tools related documentation and training... represents hovione through communications and negotiations with regulatory...

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

Represents hovione through communications and negotiations with regulatory authorities, preparing, submitting and managing all matters related to regulatory submissions...

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

Clear and open communication skills (written and verbal)... carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply...