Role & responsibilities

Preparation & Review of Qualification Documents.

Issuance of all department formats & logbooks.

Preparation & Review of SOP's.

To Review Calibration Reports.

Preparation of Management Review Report.

To Review Temperature Mapping Reports.

Handling of QMS Documents.

Handling of Market Complaint.

Handling of Vendor Qualification Documents.

To review self-inspection Report

Handling of HVAC Re-Qualification activity & review of Documents.

Ensure the implementation and compliance with GMP aspects as trained on.

Handling of Compressed Air validation activity.

Ensure compliance with integrity of data as trained on.

Execution of Equipment Qualification activity.

To Review batch manufacturing record & Batch packing records.

Preparation & review of Validation Master Plan & Site Master File.

Functional Reporting & Administrative Reporting to Head QA.

To review yearly Balance Calibration Reports.

To perform and participate regular Self-inspection as per the schedule and verifying the compliance.

To review Preventive Maintenance Documents.

To perform Audit of contract laboratory.

To review Water System Documents.

📌 Executive -QA (Qualification) (Vapi)
🏢 S Kant Healthcare
📍 Vapi