Deputy Manager

4 days ago

India Biocon Full time

Department Details Role Summary PRIMARY RESPONSIBILITIES Ensures that designs meet regulatory requirements quality standards and company policies throughout the product lifecycle FDA 21CFR Part 820 Quality System Regulation ISO 13485 Regulations ISO 14971 Review design documentation specifications and data to identify potential compliance gaps and quality issues Responsible for developing and implementing compliance programs identifying potential issues and recommending corrective actions to ensure product safety reliability and efficacy Maintain accurate and up-to-date documentation related to compliance activities including test results reports and procedures Hands-on experience in Design History File compilation Technical file documentation Experience in complaint investigation corrective action and preventive action system statistical methods quality risk management and Post Market Surveillance Possess a strong understanding of design principles quality control standards regulatory requirements and problem-solving methodologies Key Responsibilities PRIMARY RESPONSIBILITIES Ensures that designs meet regulatory requirements quality standards and company policies throughout the product lifecycle FDA 21CFR Part 820 Quality System Regulation ISO 13485 Regulations ISO 14971 Review design documentation specifications and data to identify potential compliance gaps and quality issues Responsible for developing and implementing compliance programs identifying potential issues and recommending corrective actions to ensure product safety reliability and efficacy Maintain accurate and up-to-date documentation related to compliance activities including test results reports and procedures Hands-on experience in Design History File compilation Technical file documentation Experience in complaint investigation corrective action and preventive action system statistical methods quality risk management and Post Market Surveillance Possess a strong understanding of design principles quality control standards regulatory requirements and problem-solving methodologies Educational Qualifications Required Education Qualification B E Required Experience 6 - 12 years

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