Role & responsibilities

Preparation and Compilation of Process Validation protocol and reports.

Preparation and Compilation of Hold Time study protocol and reports.

Preparation and Compilation of Packaging Validation protocol and reports.

Preparation and Compilation of CPV.

Preparation of Standard Operating Procedure (SOP) related to the Quality System.

Preparation of Annual Product Quality Reviews Reports.

Control on Document and Data Pertaining to QMS System.

To Review documents/data with respect to Data Integrity.

Review of Activities with respect Data Integrity.

Issuance of Logbook and format.

To evaluate Batch Records.

Review of the Quality Documents.

Monitoring and Control of Manufacturing Workplace.

Evaluation of in process Controls.

To ensure all necessary testing carried out.

Monitoring Compliance of GMP requirement.

Retention of Records and Control sample updation and verification.

To ensure Calibration of Analytical Apparatus & Measuring Devices as per Schedule.

Administrative & Functional Reporting to GM-QA.

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