Job Description
- 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.
Apply for this Position
Ready to join ? Click the button below to submit your application.
Submit Application