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Title:  Manager - API

Custom Field 2:  2779
Location: 

Bavla, Gujarat, IN

Country/Region:  IN
State:  Guja
City:  Bavla
Company:  Dishman Carbogen Amcis Limited
Business Unit:  General
Travel: 
Description: 
  1. Preparation and review of Standard Operating Procedures.
  2. Issuance, review of OOS,OOT,Deviation,CAPA,Change Control & its Management.
  3. Handling and monitoring of control samples.
  4. To impart internal trainings to DCAL Employees.
  5. Review of Calibration records, Instrument Logs of Quality Control.
  6. To Review of Analytical Method Validation protocols and reports.
  7. Review of the Instrument qualifications and re-qualifications protocols of Quality control.
  8. Preparation & review of quality risk assessment documents.
  9. Review and approval of analytical data related to QA release.
  10. Review & Approval of Specification STP, Raw data sheet etc.
  11. To review laboratory investigations related to complaints and deviations and to ensure CAPA related to QC are completed within timeline.
  12. Internal Audit and External audit Compliance
  13. To support RA for analytical assistance.
  14. Review of working standard management and Stability studies.
  15. Handling of customer complaint, OOS, OOT, Incidents, Deviation & CAPA .
  16. Responsible and participation, review of OOS Investigation, Deviation, Complaint Investigation.
  17. To carry out any job assigned by Immediate Supervisor/HOD based on training.
  18. To maintain safety, health and environment norms and usage of personal protective equipment during work.


Job Segment: QC, Internal Audit, CAPA, Laboratory, QA, Quality, Finance, Management, Science

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