Regulatory Affairs Executive

Job Summary: Ensure manufacturing process complies with standards. Establish and update quality plans. Establish and update quality assurance procedures and specifications. Maintain and update quality assurance records. Data analysis and continual improvement Complaints handling Lead or participate in the investigation root cause determination of internal and external complaints. Initiate and implement corrective and preventive action. Document the complaint investigation, CAPA and closure of complaints. Direct and drive quality objectives. Co-ordinate with production and R&D to identify realistic and impactful quality objectives and focal for each objective. Monitor the progress of each objective and aid focals to achieve the objectives. Document and update the objectives Internal quality audit and External audit Ensure availability of documents at the time of audit. Co-ordinate with regulatory team and fulfill the audit requirements. Ensure timely closure of audit findings. Prepare DMR for new products. Co-ordinate with R&D team in preparation of documents such as quality plan, SOPs, Risk analysis, MDD documents and technical specification etc.

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