Job
Description
Role & responsibilities 1. Monitoring and Managing the Quality Management System (QMS) Oversee the effective implementation and maintenance of the QMS across all departments. Ensure compliance with regulatory standards such as GMP, GLP, and ISO guidelines. Regularly review and update QMS documentation to reflect current practices and regulatory changes. Facilitate continuous improvement initiatives within the quality system. 2. Participation in Compliance, Investigations, and CAPA Effectiveness Lead investigations into quality deviations, non-conformances, and product complaints. Implement Corrective and Preventive Actions (CAPA) to address root causes. Verify the effectiveness of CAPAs to prevent recurrence and ensure product quality. 3. Preparation and Review of Quality Meetings and Documentation Prepare comprehensive reports for quality review meetings. Review and approve documentation related to technology transfers, validation, and process changes. Maintain accurate records to support regulatory audits and inspections. 4. Handling Non-Conformances and document issue,retrieval and storage: Escalate non-conformances promptly and coordinate remediation activities. Ensure document issue, retrieval and storage of documents. 5. Ensuring Good Documentation and Manufacturing Practices Enforce adherence to Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP) Conduct regular training sessions for personnel on quality standards and documentation procedures. 6. Timely Closure of QMS Documents Ensure all QMS-related documents, including CAPA reports, change controls, market complaints and deviations, are closed within stipulated timelines. 7. Standard Operating Procedures (SOPs) and Training Develop, review, and update Standard Operating Procedures (SOPs) for various quality processes. Conduct training on SOPs and quality practices for staff to ensure consistent compliance. 8. Preparation and Maintenance of Regulatory Documentation Responsible for preparing and maintaining the Site Master File (SMF) in accordance with regulatory requirements. Support regulatory audits by providing accurate and timely documentation. 9. Implementation of Data Integrity Procedures Ensure strict adherence to data integrity principles across all quality data. Conduct periodic reviews and audits to verify data accuracy and compliance. 10. Audit Compliance and Continuous Improvement Maintaining audit readiness is a key aspect of this role. You will be responsible for ensuring compliance during internal and external audits, identifying areas for improvement, and implementing corrective actions to enhance overall quality systems. Preferred candidate profile Proven experience (10+ years) in QA/QMS within the pharmaceutical industry, especially in API and formulations. Strong knowledge of GMP, GLP, ISO standards, and regulatory requirements. Experience in handling QMS documentation, CAPA, deviations, market complaints and change controls. Excellent communication, leadership, and training skills. Ability to manage multiple projects and meet strict deadlines.
