Quality Assurance Associate - Packing
Job Description
Drug Product Department Manufacturing Assurance and responsible for ensuring quality assurance of sterile drug products Visual inspection and packing operations.
Ensure timely closure of BPR review, incidents and change controls pertaining to Visual inspection and packing operations.
Primary Responsibilities:
• To monitor and ensure that all activities involved in visual inspection, labelling and packing functions are in compliance with GMP and Standard operating procedures.
• To perform periodic verification of GMP records to ensure that data generated and documented at GMP floor are in compliance with ALCOA principle.
• To ensure shop floor compliance by involving in Line Clearance activities for Optical Inspections and packaging activities.
• To ensure and comply the finished product time out of refrigeration and material management with in Production- Packing
• Review and approval of executed batch records for packaging operations
• Review and approval of revised SOPs, BPRs, MFRs, Validation Protocols etc.,
• Review and approval of Change Controls, Incidents, CAPAs pertaining to optical inspection, packing, dispatches.
• To support for new product launch with respect to drug product packaging.
• Ensure Process and Product change over line clearances for packaging related activities in shifts as per the approved procedures.
• Review and approval of MFRs, BOMs, BPRs, & SOPs related to packaging operations.
• To support, monitor Transport Validation activities.
• To verify temperature data of export shipments.
• Review and approval of BOM, artwork management will be an added advantage.
• Automatic Visual Inspection machine knowledge and automatic packing line operations.
Requirements
Function: Other
Experience Level: Mid-Senior Level