Commercial Distribution Quality Assurance:
Warehouse/ CFA Audit/ Service Provider:
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Creating and maintaining warehouse/ CFA/ Service Provider audit schedule
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Conducting Internal audits of CFAs/ Hubs
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Tracking and closure of audits
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Quality visits at warehouses / CFA’s as necessary.
Managing Suppliers and performing qualification/ performance assessment/
re- qualification activities
Tracking and timely closing CAPA on identified action points arising out of:
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Regulated monitoring activities
Identification, preparation, review and updating of Distribution Quality SOPs/ Quality Manual/ documents meeting requirements of regulatory and Abbott (Corporate & Divisional documents)
Ensuring over labeling controls at approved Over-labelling facilities in line with Abbott standards
Reviewing temperature data of data loggers of imported cold chain products and further sharing approvals to import department
Reviewing and approving temperature excursions of products observed during storage & distribution of temperature sensitive products and description reports to mitigate product risks
Maintaining calendar for temperature mapping of Warehouse & CFA locations, reviewing and approving temperature mapping documents
Monitoring OTMS related activities at Warehouse & CFA locations and ensuring
compliance as per requirements
Trend analysis for Pest control activities and excursions