Executive Quality Assurance

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.