Quality Management System Development and Implementation
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- Develop and ensure implementation of the quality management system as per applicable regulatory guidelines.
- Ensure quality processes are implemented across the organization, review any deviations, and recommend corrective actions.
- Provide guidelines on various stages of new product and analytical development.
Regulatory Compliance and Documentation:
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- Ensure timely submission of regulatory dossiers to authorities.
- Ensure that all business activities, from production to packaging, including raw materials, in-process, and finished goods dispatch, comply with regulatory guidelines, standard operating procedures (SOPs), and internal quality norms
Audit and Certification Management:
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- Coordinate with R&D, Corporate, and Production teams for audit preparations, facilitating external audits by authorities, customers, partners, and buyers.
- Ensure smooth conduct of audits and timely achievement of targeted certifications.
- Ensure timely resolution of customer and audit queries.
- Monthly Management Review Reports & Presentations
- Ensure testing of raw materials, in-process items, and finished goods is conducted as per applicable protocols
Quality Control and Process Oversight:
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- Oversee the approval process for finished goods dispatch to ensure all protocols, SOPs, and quality norms are followed.
- Review corrective and preventive actions (CAPA) for any quality or operational issues identified during inspections and ensure their implementation.
- Analyze inspection data and recommend process improvements where necessary.·
Data Analyzing & Training :
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- Study consolidated analysis/MIS reports from Quality Control to analyze trend data and devise control mechanisms as needed.
- Conduct regular training programs for functional and other employees on various quality-related aspects.