Act as complaint coordinator for market complaint acknowledgement, logging, investigation, response preparation, response sharing & closing.
Compilation of Quality Metric in co-ordination with other department.
Initiation and logging of Management Notification related to Quality event.
Preparation, tracking and logging of Field alert Report and customer notification.
Product Recall tracking and logging.
Logging & investigation of temperature excursion reported during transit in co- ordination with supply chain department.
Preparation and review of Departmental SOP's to meet cGMP requirements.
Coordinating with QP / customer for approval of Change controls / Deviations, Process Validation & Stability Protocol and handling queries related to documents.
Review of Risk assessment protocols & reports.
Preparation & Review of Annual Product Quality Review.
To perform review of change control in Trackwise.
To initiate effectiveness check in Trackwise.
To perform QA approval of extension request in Trackwise.
To prepare audit response & monitoring of associated CAPA.
To review of investigation related to deviation, complaints & OOS/OOT.
Closure of CAPA in Trackwise.
Day to day data compilation as per requirement assigned by Head QA.
