Executive Quality Assurance

Job Description

Role & responsibilities Issuance and tracking of QMS documents like deviation, Change management forms, Continual improvement form. Document control includes distribution and archival of documents along with tracking of design change request forms. Preparation of labels for shipment and checking of shipping documents. Monitoring of dispatch. Monitoring of in process activities along with documentation and reporting. Participation in the audit programs internal and external as per key responsible area. Participation in training activities as per the plan. Training fellow team members as per the functional requirement. Preparation of data required for various process and analysis at various stages of operation. Participation in risk identification process as per the job assigned. Monitoring of calibration, validation and equipment qualification activity in the facility. Monitoring of preventive maintenance activity and documentation. Monitoring of process validation activity and documentation. Review of batch processing and testing records. Preparation of documents like SOP and records. Processing of purchase requests in Netsuite ERP. Review of artworks and maintaining its traceability across revisions Approval of product/material code assigning. Maintaining the documentation and traceability of customer complaints and feedback. Arrangement and storage of documents in QA and document storage area ensuring its safe keeping. Working closely with interfacing departments for effective QMS. Skills & Competencies: Knowledge of scope of QMS. Awareness of the ISO 13485:2016 and ISO 9001:2015 requirements. Knowledge of QA SOP and documentation related to process handled. Significance of Role of QA in the process areas and release with respect to product. Knowledge of interdepartmental procedures as per the job assigned. Operation of MS office-MS Excel and MS word.