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:
- Preparation and review of Standard Operating Procedures.
- Issuance, review of OOS,OOT,Deviation,CAPA,Change Control & its Management.
- Handling and monitoring of control samples.
- To impart internal trainings to DCAL Employees.
- Review of Calibration records, Instrument Logs of Quality Control.
- To Review of Analytical Method Validation protocols and reports.
- Review of the Instrument qualifications and re-qualifications protocols of Quality control.
- Preparation & review of quality risk assessment documents.
- Review and approval of analytical data related to QA release.
- Review & Approval of Specification STP, Raw data sheet etc.
- To review laboratory investigations related to complaints and deviations and to ensure CAPA related to QC are completed within timeline.
- Internal Audit and External audit Compliance
- To support RA for analytical assistance.
- Review of working standard management and Stability studies.
- Handling of customer complaint, OOS, OOT, Incidents, Deviation & CAPA .
- Responsible and participation, review of OOS Investigation, Deviation, Complaint Investigation.
- To carry out any job assigned by Immediate Supervisor/HOD based on training.
- To maintain safety, health and environment norms and usage of personal protective equipment during work.
Job Segment: Internal Audit, Manager, CAPA, Quality Assurance, Laboratory, Finance, Management, Technology, Science
