Followings will be the Job Responsibilities of the position holder:
1. To initiate Change Control and perform impact assessment.
2. To perform investigations related to deviation / OOS / OOT and market complaints to identify the root cause and implementation of appropriate CAPAs.
3. To ensure the compliance of quality notifications like deviations and investigations for proper closure. Review of non-conformances, deviations, change controls, internal audits, annual product quality reviews and to perform assessment on other impacting documents and related activities.
4. Handling of Track wise software, SAP and Documents compliance software’s.
5. To perform and participate in Quality risk management exercises whenever required.
6. To perform the gap analysis with respect to cGMP guidelines, current regulatory requirements, and SOPs, wherever required and to comply with the requirements and implement the same.
7. To ensure proper training to all the concerned personnel with respect to investigation outcomes.
8. To ensure compliance at shopfloor with respect to SOPs.
9. Preparation and review of Standard Operation Procedure.
10. To follow the environmental, health and safety policy of organization.
11. To perform any other task as assigned by the department manager.
The base pay for this position is
In specific locations, the pay range may vary from the range posted.