Dishman Carbogen Amcis logo

Manager - API

0 years

0 Lacs

india

Posted:5 days ago| Platform: GlassDoor logo

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Skills Required

api monitoring calibration risk assessment data qc audit support management stability

Work Mode

On-site

Job Type

Part Time

Job Description

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.

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Dishman Carbogen Amcis logo
Dishman Carbogen Amcis

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