
Operations Specialist
2 days ago
Job Overview:
This role is responsible for overseeing and executing equipment operation, visual inspection, and packing activities in compliance with GMP and quality protocols. The position involves documentation, coordination with cross-functional teams, equipment qualification, and QMS adherence.
Main Responsibilities:
- To perform equipment operation and cleaning
- To supervise visual inspection and batch packing execution as per plan
- To maintain documentation as per batch record and SOP
- To conduct equipment qualification as per protocols and SOP
- Responsible for maintaining documents as per cGMP norms
- Coordinate with cross-functional teams for day-to-day activities
- Responsible for SOP, MPR, and BPR preparation and revision
- Coordinate with team to execute daily packing and visual inspection plan
- Ensure training completion before performing any activity
- Raise batch record requests as per plan
- Responsible for QMS-related activities (Change Control, Deviations, Batch Records) in packing and visual inspection
- Monitor day-to-day activities
- Report all activities, incidents, and issues to the reporting officer
Key Skills:
- Equipment operation and maintenance
- Visual inspection and quality control
- Documentation and records management
- Equipment qualification and validation
- cGMP compliance and regulations
- Team coordination and communication
- SOP development and implementation
- Batch record management and tracking
- QMS adherence and audit readiness
Benefits:
- Opportunity to work in a dynamic environment
- Chance to develop skills and expertise
- Collaborative team atmosphere
- Continuous learning and growth opportunities
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