To assist the Quality Assurance Manager (QAM) in ensuring that appropriate quality systems are established
• Will assist in the development, continuous review, implementation, correction and traceable distribution of Policies (POLs), Standard Operating Procedures (SOPs) and Guidelines (GUIs) and ensure that they are in compliance with applicable regulations such as but not limited to ICH, Helsinki declaration, Competent Authorities, EMA, FDA• Will assist in ensuring that regular, systematic internal and external quality audits are conducted as in order to verify compliance with the current applicable POLs, SOPs and GUIs and other applicable standards and regulations (e.g. ICH, Helsinki declaration, Competent Authorities, EMA, FDA, etc.)
• Will assist in compiling reports of audit findings, creating and following-up on implementation of CAPA recommendations• Will assist in tracking of deviations and related actions
• Will assist in employees’ training follow-up and training records filing• Will assist in keeping up-to-date the quality database
• Will work in a close collaboration with the M4Q committee to help to ensure that objectives are met• Good understanding of the clinical research processes, Good Clinical Practices (ICH-GCP /ISO14155) and applicable standards and regulations. Quality auditing experience certification or training preferred.
• Fine attention to details• Effective problem-solving skills
• Proficient in English• Computer literacy (Word, Excel, PowerPoint)