Company Overview
Role Purpose
Academic Stream
Work experience (in months)
Job Responsibility and key Decisions
Deviation Handling
Log, review, and support investigation of deviations occurring in the drug product manufacturing process.
Ensure that investigations are thorough, timely, and compliant with procedures.
CAPA Tracking and Implementation
Monitor the lifecycle of CAPAs to ensure timely closure and verify effectiveness where required.
Support QA Leads in tracking overdue actions and escalating as needed.
Change Control Execution
Support initiation and management of change controls related to DP manufacturing processes, methods, or documentation.
Ensure changes are assessed for impact, documented appropriately, and closed within timelines.
Document Control and Quality Records
Assist with document routing, review coordination, and archival of controlled quality documents.
Ensure that master document lists and SOP trackers are current and accurate.
Internal Audit Preparation
Support planning, scheduling, and coordination of internal audits and selfinspections.
Help collect documents and compile responses to audit observations.
Regulatory Inspection Support
Participate in preparing documentation and data for regulatory inspections.
Support QA leads in managing inspection logistics and postinspection followups.
Metrics and Reporting
Assist in compiling data for QMS performance metrics e.g., deviation trends, CAPA timelines, audit outcomes.
Support periodic quality review meetings with relevant data and documentation.
DecisionMaking Scope
Make recommendations related to documentation improvements, investigation followups, and minor QMS optimizations.
Escalate critical quality risks, overdue actions, or systemic issues to QA leadership.
