QA Executive

Roles and Responsibilities

• Maintain accurate records of all quality-related activities and reports.
• Conduct quality audits, internal audits, BMR review, capa, change control, GMP compliance, deviation management.
• Ensure adherence to cGMP guidelines during production runs.
• Identify areas for improvement through continuous monitoring of processes and implement corrective actions.
• Collaborate with cross-functional teams to resolve quality issues and improve overall productivity.
• Document issuance (i.e., Batch Manufacturing Record , Lab Note Book, Log books, analytical work sheets, SOP formats etc.,)
• Review of executed documents (e.g., Batch Manufacturing Record, analytical work sheets Equipments usage log books, area cleaning records, calibration records, preventive maintenance records, Lab Note Book,)
• Retrieval and archival of quality management system related documents.
• Preparation of annual schedules (GMP training schedule and On Job Trainings, Preventive Maintenance, Equipment calibration, Internal Audit and Management Review Meeting) and conducting according to these schedules.
• Initiate the change control, deviation related to quality functions.
• Preparation of Certificate of analysis
• Coordinating with External Testing Laboratories.
• Reviewing the completed analytical reports, Calibration reports for its compliance.
• Reviewing the Instrument/Equipment master Calibration schedules for its compliance.
• Assistance for the new analytical method development and validation as per the guidelines.