Job Description
Followings will be the responsibilities of the position holder:
1. Annual Product Quality review:
- Preparation and compilation of data
- Identification of manufacturing investigation trends related to the product and determining if adequate corrective and preventive action was taken.
- Effectiveness verification of corrective and preventive actions within the APQR scope.
- Statistical analysis and graphing of critical parameters for trend identification.
- Analysis of all APQR data inputs to identify emergent adverse trends amongst various quality systems (ex. manufacturing investigations, complaints, analytical data, etc.) and recommending appropriate corrective/preventive action.
2. Review of Executed batch record and its release to market
3.
Continuous Process Verification
4. Trending and Analysis of process capability index and check of process control.
5. To carry forward and execution of projects toward complaint reduction.
6. Preparation & revision of QA relevant SOPs.
7. To ensure completion of all assigned trainings with in stipulated timeline.
8. To investigate Exceptions and proposed CAPA.
9. Quality Metrices and Management Review- To collate, review and update the data for the monthly Quality metrices and Quarterly Management Review.
10. To track and Monitor QIPs initiated at the Site.