Qms Executive

Stanford Laboratories; Nimera; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Stanford Laboratories is seeking a GMP-compliant production quality professional in India to oversee QMS documentation, batch execution, deviations, and continuous improvement initiatives. The role requires coordinating with QA for line clearance and maintaining data integrity across electronic systems.

The candidate will train production staff on cGMP and SOPs, ensuring preparedness for regulatory audits and inspections, while driving CAPA and deviation management to uphold manufacturing

Responsibilities

• QMS Compliance & Documentation: Prepare, review, and maintain SOPs, BMRs, and related production documents.
• Batch Execution & Monitoring: Monitor batch manufacturing processes to ensure adherence to approved procedures; coordinate with QA for line clearance and in-process checks.
• Deviation & Investigation Handling: Initiate and investigate production-related deviations; prepare investigation reports and implement CAPAs.
• Training & Compliance: Conduct training for production staff on cGMP, SOPs, and QMS requirements; ensure readiness for regulatory audits and inspections.
• Continuous Improvement: Participate in root cause analysis and process improvement initiatives; support data integrity practices and electronic documentation systems.

Job description

Key Responsibilities

• QMS Compliance & Documentation
  
  • Prepare, review, and maintain SOPs, Batch Manufacturing Records (BMR), and related production documents.
  • Ensure timely closure of deviations, change controls, and CAPAs related to production activities.
  • Maintain compliance with global regulatory standards.
• Batch Execution & Monitoring
  
  • Monitor batch manufacturing processes to ensure adherence to approved procedures.
  • Coordinate with QA for line clearance and in-process checks.
• Deviation & Investigation Handling
  
  • Initiate and investigate production-related deviations.
  • Prepare investigation reports and implement corrective and preventive actions (CAPA).
• Training & Compliance
  
  • Conduct training for production staff on cGMP, SOPs, and QMS requirements.
  • Ensure readiness for regulatory audits and inspections.
• Continuous Improvement
  
  • Participate in root cause analysis and process improvement initiatives.
  • Support implementation of data integrity practices and electronic documentation systems.