EMPREGO REGULATORY AFFAIRS SAFETY AND LOURES, LISBOA

Develops and maintains comprehensive knowledge and familiarity of regulatory and organization requirements and standards and works to ensure these requirements are...

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

) and activities... training and experience of gmp and hse practices (mandatory) ... apply and develop knowledge of engineering and participate in area processes...

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... represents hovione through communications and negotiations with regulatory...

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

Method development, method and specification creation; method transfer, protocols and reports preparation for rm, in and fp... recommends the analytical characterization...