Officer/Senior Officer - Production QMS

Key Responsibilities:

• Deviation Management & Investigation
• Identify and document deviations in the production process
• Conduct thorough investigations and implement corrective actions
• Root Cause & Impact Analysis
• Perform detailed root cause analysis and assess the impact on product quality and safety
• Market Complaint Handling
• Lead investigations and resolve market complaints in coordination with QA/QC
• Prepare detailed reports and response documents
• CAPA (Corrective & Preventive Actions)
• Track and ensure timely implementation of CAPAs
• Monitor effectiveness and support closure
• Change Control & Risk Assessment
• Handle change control processes for production operations
• Perform risk assessments for proposed changes
• Documentation & Compliance
• Prepare and review Batch Manufacturing Records (BMR), protocols, and SOPs
• Ensure documentation adheres to cGMP and regulatory standards
• Audit & Internal Compliance
• Support internal and external audits (Regulatory, Client, ISO, etc.)
• Address audit observations and implement improvements
• Maintain readiness for inspections at all times

Interested candidates can also mail their resume on [email removed]