Conduct Internal Quality Audits and ensure timely compliance and closure of audit observations.
Review Change Controls, Deviations, and Standard Operating Procedures (SOPs).
Review and ensure the adequacy and effectiveness of investigations and risk assessments arising from OOS, OOT, market complaints, and other quality-related events.
Participate as a Cross Functional Team (CFT) member in investigations.
Track, document, and review Corrective and Preventive Actions (CAPA) and ensure their adequacy and effectiveness.
Handle Out of Specification (OOS) and Out of Trend (OOT) investigations and prepare the required documentation.
Prepare Holding Time and Stability Study Protocols and review stability and holding time data.
Review, evaluate, and track Change Controls as per approved SOPs.
Review, evaluate, and track Deviations as per approved SOPs.
Provide necessary support and prepare responses for external audits, including regulatory and customer audits.
Review Process Validation Protocols and Reports.
Review Cleaning Validation Protocols and Reports.
Review Computer System Validation (CSV) documentation.
Review Equipment Qualification documents.
Review Technology Transfer documents.
Ensure manufacturing processes remain in a state of continuous validation.
Review qualification and approval documents of Contract Service Providers (CSPs).
Provide documentation support to Regulatory Affairs, Marketing Department, and Customers.
Prepare Annual Product Reviews (APR).
Handle and coordinate functional and GMP training activities.
Review qualification, requalification, calibration, validation, and revalidation documents related to equipment, instruments, and utility systems such as HVAC, Dynamic Pass Box, LAF/RLAF, Nitrogen, Compressed Air, and Water Systems.
Review Facility Assessment Reports.
Prepare and review Risk Assessment Reports.
Review Temperature Mapping Protocols and Reports.
Review Instrument Calibration Certificates.
Review Preventive Maintenance Schedules, Calibration Schedules, Equipment Lists, Instrument Lists, Layouts, P&ID documents, and other related schedules.
Review Master BPCR/ECR documents based on Technology Transfer Dossiers or Process Development Reports.
Update and maintain the Site Master File (SMF) and Validation Master Plan (VMP).
Conduct daily inspections of manufacturing areas to ensure compliance with Good Manufacturing Practices (GMP).
Job Overview
Date PostedJun 10, 2026
Expiration DateMar 01, 2027
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