کارشناس تضمین کیفیت و رگولاتوری

Job Description

• Ensures that current registration requirements are available, communicated and implemented both with Iran’s MOH and related foreign companies • Managing for preparation of all required documents such as guidelines, specifications, certificates and reports for different departments • Compiles and submits registration files for new products • Gathering and preparing the documents for Iran’s Drug’s List • Follow-ups with the Iranian Ministry of Health on files review and ensures timely submission of additional documentation requested • Keeping up-to-date with changes in regulatory legislation and guidelines • Ensures registration information system (RIMS) is updated according to the latest approved regulatory data in territory • Interpret and implement quality assurance standards - Evaluate the adequacy of quality and preparation of all required SOPs and updating documents and collaborate with different departments and monitoring system • Assurance standards - Review the implementation and efficiency of quality and inspection • Document internal audits and other quality assurance activities – Investigate • customer complaints and non-conformance issues - Collect and compile statistical quality data - Analyze data to identify areas for improvement in the quality system and Development, • training interventions to meet quality standards - Coordinate and support on-site audits conducted by external providers - Evaluate audit findings and implement appropriate • Assists in the maintenance of company's compliance with respect to laws, regulations and guidance during different clinical trials and Pharmacovigilance • Assures the correct implementation and observation of all safety related Standard Operating Procedures (SOPs) and Working Procedures (WPs) , Collects, reviews and assess the adverse event information regarding in all therapeutic areas; Prepares and submits the individual case safety reports to the local Health Authorities of the Iran according to the local regulations • Contributes in local safety observation detection and review of relevant medical literature according with the PV standard operations and procedures • Continues Report to Head of Regulatory Department