Roles and Responsibilities
- Maintain accurate records of all quality-related activities and reports.
- Conduct quality audits, internal audits, external audits, customer audits, BMR review, capa, change control, OOS, GMP compliance, deviation management, root cause analysis, SOP preparation, and QMS implementation.
- 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
- Preparation of Shipment Documents.
- Coordinating with External Testing Laboratories.
- Review of OOS, OOT, Deviation, Change controls, Investigation reports, Risk assessment reports, Instrument Audit Trail reports and CAPA for its compliance and approval.
- Reviewing the completed analytical reports, Calibration reports for its compliance.
- Reviewing the Instrument/Equipment master Calibration schedules for its compliance.
- Ensuring the stability studies are conducted by QC as per the defined storage conditions on APIs and/or Intermediates where appropriate.
- Conducting internal audits to various departments for the continuous improvement of Quality.
- Assis

📌 QA Lead/QA Sr Executive (Maddipadu)
🏢 Bezwada Biomedical
📍 Maddipadu