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.
Assistance for the current analytical method development and validation as per the guidelines.
Assistance for the monthly GMP audit
Testing of in-process samples in the absence of quality control designee.
Daily calibration of analytical instruments in the absence of quality control designee.
Management of control samples in the absence of quality control designee.

📌 Qa Lead/qa Sr Executive Prakasam
🏢 Bezwada Biomedical
📍 Prakasam