Responsible for managing all aspects of Quality Assurance at site including In-process QA, Quality Management System, Analytical QA, QA-Validation, and Documentation. Execute Quality Assurance goals and strategy in line with Quality management objectives and regulatory requirements. Accountable for quality of products manufactured and dispositioned at site.
Proactively assess quality issues at site and ensure compliance to QA regulatory requirements in manufacturing operations at site. Monitor and track quality assurance metrics with site manufacturing/QC management and other cross-functions. Facilitate for all-time readiness of the site for any internal and regulatory agency audits/inspections at any given point of time.
Responsibilities: Responsible for defining operational strategy and road map for Quality Assurance management at site. Execute site Quality Assurance goals and strategy in line with Sun Pharma compliance, product quality management objectives and regulatory requirements.Effectively manage the site Quality Assurance activities and resources necessary to smoothly run the QA operation at site.Responsible for batch disposition of the products.Provide strong leadership and expertise to ensure achievement of all Quality Assurance goals business and functional at site.Identify and implement solutions for improving existing site Quality Assurance systems and processes.Coach and develop both direct and, as appropriate, indirect reports through ongoing, example-based performance feedback, annual performance reviews, and the provision of training and development opportunities.Ensure that performance issues are managed in a consistent and timely manner.Responsible for ensuring availability of adequate resources, including manpower to maintain compliance with GXP requirements.Assure all-time readiness of site for regulatory agency inspections/internal audits and appropriate implementation of corrective actions regarding observations made by the agencies/internal audit teams.Responsible for executing Quality Management Reviews at site, monitor individual performance, and set improvement areas.Responsible for managing the Quality Management Systems ensuring market complaints, failures, deviations are investigated and corrective and preventive actions are implemented as per set timeline.Responsible for ensuring compliance to regulatory requirements on product, process, and release procedures. Ensure release of safe and effective drug products from site as per cGMP requirement and regulatory commitment.Accountable for designing/implementing and ensuring compliance to all quality-related SOPs, Policies, Standards, and QA systems at the site.Facilitate internal and regulatory agency audits, ensuring that findings from site audits are understood, assessed, and addressed site-wide in a comprehensive manner.Monitor industry trends/issues faced internally and identify scope for improving site Quality Assurance management and processes.The authorization of written procedures and other documents, including amendments.To ensure that the required initial and continuing training of his department personnel is carried out.Performs all work in support of our Corporate Values of Pride, Accountability, Integrity, and Diligence. Performs all work in accordance with all established regulatory and compliance and safety requirements.To ensure that the appropriate validations/qualifications are done as per procedure.Responsible for effectively managing the change control and quality risk management process at site & ensuring all requirements of the process are adhered to and providing approvals.
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