Executive - QA (Process Validation)

S Kant Healthcare; Valsad District; On-site; INR 650,000 - 900,000; Full time

Job summary

S Kant Healthcare in Gujarat, India seeks a QA/QC professional to prepare and compile validation protocols, CPV and related QA documentation within a GMP environment.

You will review data integrity, manage QMS documents, and ensure calibration of analytical equipment while preserving records and supporting annual quality reviews.

Responsibilities

• Preparation and compilation of Process Validation protocols and reports.
• Preparation and compilation of Hold Time study protocols and reports.
• Preparation and compilation of Packaging Validation protocols and reports.
• Preparation/compilation of CPV (Critical Process Validation).
• Drafting SOPs related to the QMS.
• Annual Product Quality Review reports.
• Control of documents and data pertaining to the QMS.
• Review of data with respect to data integrity.
• Review of activities with respect to data integrity.
• Issuance of logbooks and formats.
• Evaluation of batch records.
• Review of quality documents.
• Monitoring and control of manufacturing environment.
• Evaluation of in-process controls.
• Ensure all necessary testing is carried out.
• Monitoring compliance with GMP requirements.
• Retention of records; update and verification of control samples.
• Calibration of analytical instruments and measuring devices as per schedule.
• Administrative reporting to GM-QA.

Job description

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 Environment.
• 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.