کارشناس تضمین کیفیت و رگولاتوری

تچرا دارو تهران

منتشر شده 2 سال پیش

Job Description

● Ensure that current registration requirements are available, communicated, and implemented both with Iran’s MOH and related foreign companies. ● Manage for preparation of all required documents such as guidelines, specifications, certificates, and reports for different departments. ● Compile and submit registration files for new products. ● Gather and prepare the documents for Iran’s Drug List. ● Follow-up with the Iranian Ministry of Health on files reviews and ensure timely submission of additional documentation requested. ● Keep up-to-date with changes in regulatory legislation and guidelines. ● Ensure the registration information system (RIMS) is updated according to the latest approved regulatory data in the territory. ● Interpret and implement quality assurance standards. ● Evaluate the adequacy of quality and preparation of all required SOPs and update documents and collaborate with different departments and monitoring systems. ● Review the implementation and efficiency of quality and inspection. ● Document internal audits and other quality assurance activities. ● 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. ● Train interventions to meet quality standards. ● Coordinate and support on-site audits conducted by external providers. ● Evaluate audit findings and implement them appropriately. ● Assure the correct implementation and observation of all safety-related Standard Operating Procedures (SOPs) and Working Procedures (WPs), collect, review, and assess the adverse event information regarding all therapeutic areas. ● Prepare and submit the individual case safety reports to the local health authorities of Iran according to the local regulations. ● Collect and archive relevant documents both systemic and paper base. ● Conduct any reverent work in respect of regulatory and quality assurance.

Requirements

● Bachelor's or Master's degree in Chemistry. ● 3 to 4 years of experience in the regulatory and quality assurance-related fields. ● A good understanding of the relevant Iranian MOH and quality framework. ● Familiar with the procedure of TTAC. ● Effective time management skills, ability to handle multiple projects and tasks simultaneously. ● Fluency in English is required. ● Teamwork. ● Age range: 28 to 40 years old.

برای مشاهده‌ی شغل‌هایی که ارتباط بیشتری با حرفه‌ی شما دارد،