Quality Assurance Expert

Omid Darou Salamat Tehran

Posted a year ago

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Job Description

● Manage the preparation of all required documents such as guidelines, specifications, certificates, and reports for different departments. ● Keep up-to-date with changes in regulatory legislation and guidelines. ● 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 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 quality assurance-related fields. ● A good understanding of the relevant Iranian MOH and quality framework. ● Effective time management skills, and ability to handle multiple projects and tasks simultaneously. ● Fluent in English. ● Familiar with quality assurance and international regulation e.g.; FDA, EU, etc. ● Sense of human relations, capability to work in a team, independence, and initiative. ● Task orientation, technical knowledge, hardworking, and integrity. ● Ability to undertake multiple tasks at the same time without losing focus. ● Self-motivated individual with effective organizational skills. ● Proactive, with the ability to meet and surpass project deadlines. ● Good knowledge of Microsoft Office, especially Outlook. ● Exceptional analytical reasoning skills to think about problems thoroughly and generate solutions. ● Communication and negotiation skills. ● Time and stress management skills. ● Good command of English. ● Reliable, trustworthy, and good-tempered.

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