EMPREGO SENIOR PRODUCT SAFETY AND LOURES, LISBOA

Conducts and supports incident investigations and risk assessments... lead hse process safety communications and engagement with internal and external stakeholders...

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

Skilled at managing processes and tools... follow all applicable gmp and hse guidelines, internal and external requirements as well as promote the implementation...

Conducts and supports incident investigations and risk assessments... develops and maintains comprehensive knowledge and familiarity of regulatory and organization...

Observe and respect national legislation... competent (written and verbal) english... apply and develop knowledge of engineering and participate in area processes...

Spoken and written english... strong knowledge of industry regulations and safety standards... review and approve technical drawings, specifications, and plans...

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... 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...

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

Apply and develop knowledge of imports/exports and participate in area processes, procedures and projects with the guidance of more senior colleagues...