QA Lead/QA Sr Executive

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 new 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.