Associate Manager MQA
Core
Ensure cGMP compliance and operational quality in Terminal Sterilization, Visual Inspection, and Packaging operations for pharmaceutical products.
Role type
Associate Manager, Manufacturing Quality Assurance
Builds
Safe and effective pharmaceutical products compliant with regulatory standards
Domain
Pharmaceutical manufacturing / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, Terminal Sterilization process knowledge, Visual Inspection, Packaging operations, regulatory inspection handling (USFDA/MHRA/TGA), batch report review, equipment audit trail review, AQL sampling, batch start-up/end activities, sensor challenge tests, recipe review, equipment breakdown assessment, alarm trend analysis, process simplification, troubleshooting
Preferred skills
Quality administered systems experience, regulatory compliance documentation, mentoring, AI tool usage (ChatGPT, Microsoft Copilot)
Technologies
Microsoft Excel, Microsoft Word
Responsibilities
Ensure operating state of cGMP compliance in Terminal Sterilization, Visual Inspection and Packaging operations; Review Batch reports and Equipment audit trails; Perform Acceptable Quality level sampling, Inspection and record results; Perform batch start-up and end activities; Perform random process checks; Perform Daily walkthroughs and report observations; Review and assessment of equipment alarms and quarterly alarm trends; Identify gaps and involve in Process and Procedure Simplification; Handle regulatory, corporate and internal auditors/ inspectors
Seniority
Mid-Senior, hands-on IC
