Quality Assurance Manager

Daryan Salamat Tehran

Posted 3 years ago

Job Description

● Draft quality assurance policies and procedures. ● Interpret and implement quality assurance standards. ● Evaluate adequacy of quality assurance standards. ● Devise sampling procedures and directions for recording and reporting quality data. ● Review the implementation and efficiency of quality and inspection systems. ● Plan and monitor testing and inspection of materials and products to ensure finished product quality. ● 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. ● Develop, recommend and monitor corrective and preventive actions. ● Prepare reports to communicate outcomes of quality activities. ● Identify training needs and organize training interventions to meet quality standards. ● Coordinate and support on-site audits conducted by external providers. ● Evaluate audit findings (internal or external audits) and implement appropriate corrective actions. ● Monitor risk management activities. ● Assure ongoing compliance with quality and industry regulatory requirements. ● Ensuring that manufacturing processes comply with GMP standards at both national and international level. ● Analyze the data and recommend changes to production processes or quality controls according to change control system to eliminate the problem. ● Analyze records of product returns to identify specific problems or trends over time. ● To prepare documentation and reports by collecting, analyzing and summarizing information and trends including failed processes, stability studies, recalls, corrective actions. ● Validate quality processes by establishing product specifications and quality attributes and re-validations. ● Develop & implement quality assurance training programs. ● Preparing all quality department SOPs.

Requirements

● Education: Doctor of Pharmacy or PhD. ● Work experience: Minimum 4 years’ experience as a quality assurance manager in pharmaceutical manufacturing company. Competencies: ● Leadership Skill. ● Problem solving skill. ● Communications & interpersonal skills. ● Attention to detail. ● Analytical thinking. ● Maturity. ● Result Oriented. ● Excellent documentation skills. Others: ● Fluent in English. ● Excellent MS Office knowledge (Excel, Word, PowerPoint). ● Good numerical skill and an understanding of statistic. ● Must be familiar with Local regulatory affairs and EU GMP standards. ● Frequent traveling availability.

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