Qualifications & Skills: Bachelors degree in Pharmacy, Life Sciences, or a related field (Master’s degree preferred). Minimum 8-12 years of experience in quality management systems, production quality assurance, or training roles within the pharmaceutical industry. Strong understanding of GMP, GDP, and regulatory requirements. Experience in developing and delivering training programs in a regulated environment. Strong project management, organizational, and leadership skills. Excellent communication skills and ability to interact with all levels of the organization. QMS Implementation and Maintenance : Manage the development, implementation, and maintenance of the Quality Management System (QMS) within the production department to ensure compliance with GMP, regulatory guidelines, and internal company standards. Ensure that the QMS is aligned with regulatory bodies’ expectations (e.g., FDA, EMA, etc.) and industry best practices. Oversee the creation and periodic review of production-related documents, including SOPs, batch records, and work instructions, ensuring they are up-to-date and compliant. Quality Assurance and Compliance : Monitor and audit production processes to ensure compliance with the QMS and regulatory requirements. Identify gaps or areas of non-compliance and implement corrective and preventive actions (CAPA). Conduct internal and external audits, ensuring that all required documentation, records, and processes are in place and effective. Assist in regulatory inspections and support the production team in addressing audit findings. Training and Development : Develop and implement a comprehensive training program for production personnel on topics such as GMP, SOPs, QMS requirements, and other regulatory standards. Design and deliver training sessions, workshops, and refresher courses to ensure all team members are continuously updated on best practices and compliance requirements. Assess training needs and evaluate the effectiveness of training programs. Maintain training records and ensure that all employees have received the necessary training to perform their roles in compliance with quality standards. Continuous Improvement : Drive continuous improvement initiatives in the production department, working closely with cross-functional teams to identify areas for efficiency gains and enhanced compliance. Implement best practices for quality management and training to improve overall product quality and reduce errors or deviations. Act as a change agent to promote a culture of quality within the production team. Documentation and Reporting : Maintain accurate and up-to-date documentation for all QMS-related activities, including training logs, audit reports, and CAPA records. Prepare regular reports for senior management on the status of quality systems, training progress, audit outcomes, and any non-compliance issues. Review and approve training materials, documents, and training evaluations. Collaboration with Cross-Functional Teams : Work closely with other departments (e.g., Quality Control, Regulatory Affairs, Production, and R&D) to ensure that quality management systems are integrated into all aspects of production. Support production teams in troubleshooting quality issues and implementing solutions. Risk Management : Assess potential risks related to production processes and quality management systems. Develop and implement strategies to mitigate risks to product quality, ensuring patient safety and regulatory compliance.
