Job
Description
Position: Production QMS Executive Department: Production Location: Bangalore Reports To: Production - Manager Job Overview: The Production QMS Executive in the pharmaceutical industry ensures the seamless implementation, adherence, and improvement of the Quality Management System (QMS) within the production environment. This role involves overseeing quality assurance processes, ensuring compliance with Good Manufacturing Practices (GMP), regulatory requirements, and internal standards for pharmaceutical production. Key Responsibilities: QMS Implementation & Compliance: Implement and monitor the QMS in the production area, ensuring compliance with regulatory requirements, including GMP, FDA, WHO, and ICH guidelines. Ensure that the system effectively supports pharmaceutical production and product quality. Documentation & Record Management: Ensure that all necessary documentation related to production processes, quality checks, batch records, and compliance activities are correctly maintained. Regularly review batch records, manufacturing logs, and other related documents for completeness and accuracy. Internal Audits & GMP Compliance: Conduct internal quality audits to assess compliance with GMP and other quality standards. Identify non-conformities, and lead investigations to determine root causes, implementing corrective and preventive actions (CAPA) as required. Process Monitoring & Quality Control: Continuously monitor production processes to ensure adherence to quality specifications. Collaborate with the QC team to ensure proper sampling, testing, and evaluation of raw materials, intermediates, and final products. Training and SOP Development: Develop and conduct training programs for production personnel on quality standards, regulatory requirements, and the importance of maintaining QMS compliance. Assist in the creation, review, and updating of Standard Operating Procedures (SOPs) to ensure compliance with GMP and regulatory guidelines. Deviation and Non-Conformance Management: Investigate any deviations from production or quality procedures, prepare deviation reports, and ensure appropriate CAPA is implemented to prevent recurrence. Follow up on the resolution of non-conformances and ensure that corrective actions are effectively implemented. Risk Management & Continuous Improvement: Support the identification of quality risks in the production process and work with cross-functional teams to develop and implement risk mitigation strategies. Encourage continuous improvement in production processes and quality management practices to enhance overall product quality and compliance. Regulatory Inspections & Documentation Support: Assist in preparation for regulatory inspections (e.g., FDA, EMA) by ensuring all required documentation is up-to-date, organized, and readily available. Participate in the management of regulatory inspection findings and provide necessary documentation to address any identified issues. Collaboration with Cross-Functional Teams: Work closely with production, R&D, and QC departments to ensure alignment of quality processes and to facilitate the resolution of quality-related issues. Support product development and scale-up activities by ensuring QMS requirements are integrated into these processes. Reporting & Metrics: Generate and present regular quality metrics reports (e.g., deviations, audit results, CAPA status) to management, ensuring timely follow-up and the proper closure of quality issues. Qualifications: Education: A Bachelors degree in Pharmacy, A Masters degree or relevant certifications in quality management is an advantage. Experience: Minimum of 3-6 years of experience in a pharmaceutical manufacturing role, particularly in production environments following GMP regulations. Experience in handling QMS processes, conducting audits, and implementing CAPA is highly preferred.
