OFFICER - QA/RA

You will be responsible for various aspects of the Quality Management System (QMS) including preparation, control, retrieval, and disposition of documents. This will involve managing Master copies, Control copies, and Obsolete documents effectively. Additionally, you will be in charge of scheduling, conducting, and monitoring Internal Quality Audits, as well as following up for closure. Another key aspect of your role will be updating QA documents at different levels and maintaining the Index. You will also be involved in change control management, document retrieval during audits, handling customer complaints, and implementing Non-Conformance & CAPA procedures. Furthermore, you will manage the quality operation team to ensure the quality of product lines and deliverables. Responsibilities also include managing Batch Processing Records, maintaining the Medical Device File as per IMDR 2017, and submitting applications to CDSCO for approval. You will review the performance of the Quality Management System, liaise with external parties on related matters, and ensure that processes are documented. Reporting to top management on the effectiveness of the QMS and identifying areas for improvement will be part of your role. Promoting awareness of regulatory and management system requirements throughout the organization is also expected. Other duties may include batch release, supporting regulatory compliance, and handling any additional responsibilities as required. This is a full-time, permanent position with benefits such as food provision, health insurance, leave encashment, paid sick time, and Provident Fund. The work location is in-person.,