Job Responsibilities:
• Supervises day-to-day operations of the QMS team, ensuring all quality processes are executed efficiently and in compliance with company policies and other necessary requirements.
• Manages the deployment and maintenance of QMS processes in the assigned area/ areas such as document control, training, and internal audits, ensuring they are effective, compliant, and aligned with both regulatory requirements and business needs.
• Monitors and reports on the effectiveness of QMS processes by analyzing performance metrics, identifying trends, and developing action plans to address gaps, enhance compliance, and improve overall quality.
• Prepares for and supports external audits and inspections by ensuring all necessary documentation is available and providing detailed responses to audit findings.
• Facilitates cross-functional collaboration to resolve quality-related issues, working closely with other departments to ensure alignment and effective problem-solving.
• Manages the documentation and resolution of non-conformance reports (NCRs), ensuring systematic tracking, effective resolution, and implementation of preventive measures to avoid recurrence.
• Conducts risk assessments and manages risk mitigation activities, identifying potential risks to product quality and QMS integrity, and developing strategies to minimize their impact.
• Drives continuous improvement initiatives within the QMS, proposing and implementing enhancements to processes, tools, and systems to improve overall quality performance and operational efficiency.
• Addresses difficult to moderately complex issues or problems, requiring the evaluation of identifiable factors, following established processes and operational policies in selecting methods and techniques for obtaining solutions.
• Guides and mentors the QMS team, actively contributing to employee selection, performance management, compensation management, career development, and overseeing operational processes.
• Participates in training sessions to stay updated on quality standards and QMS procedures, actively engaging in learning opportunities to enhance understanding of industry regulations and best practices.
• Manages compliance to NMPA regulations and other Regulatory Agencies as required, guidelines and policies to all products and operations are consistent with those regulations.
• Manages the review and approval of finished products manufactured for and by the company in accordance with their approved specifications.
• Manages all inspections and questions relating to the operation of Goldway sites in coordination with all other applicable company groups
• Manages product recall activities to include recall policies and procedures for the company. Additionally, manage product compliant activities and all other post marketing surveillance activities.