JOB DESCRIPTION:
Core Job Responsibilities:
1
Commercial Distribution Quality Assurance:
Warehouse/ CFA Audit/ Service Provider:
Creating and maintaining warehouse/ CFA/ Service Provider audit schedule
Conducting Internal audits of CFAs/ Hubs
Tracking and closure of audits
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:
One Affiliate Program
Regional Supplier Audit
Regulated monitoring activities
Exceptions
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
Customer Complaints handling
Receiving, logging in, acknowledging, complaint sample follow up & intimating to manufacturing site for received complaint and further supporting the investigation team
with relevant information to facilitate effective investigation.
Logging information of complaint in SolTRAQ/Trackwise.
Connecting with cross functions and Business teams, as necessary to keep the team aware
of the complaints management system and selective cases, as necessary.
Ensuring complaint sample retrieval and e