Executive - QMS - Quality Assurance

Role & responsibilities

Hands on experience required on handling of investigation review of Deviation, change control and CAPA

• Develop, implement, and maintain the organizations Quality Management System (QMS) in compliance with regulatory standards such as ISO 9001, GMP, and other applicable guidelines.
• Regularly review and update QMS documentation, including policies, procedures, and work instructions.

• Plan, execute, and support internal and external audits, including regulatory inspections and certification audits.
• Monitor compliance with QMS requirements and regulatory standards, addressing gaps and ensuring timely resolution of audit findings.

• Manage the documentation, investigation, and resolution of deviations, ensuring root cause analysis and effective implementation of corrective and preventive actions (CAPAs).
• Oversee change control processes, assessing and approving changes to ensure alignment with quality standards.

• Maintain and control QMS documentation, ensuring accurate and timely updates.
• Ensure proper archiving, retrieval, and distribution of quality records and documents.