Manager - API

4 days ago

Bavla Gujarat, India Dishman Carbogen Amcis Ltd Full time ₹ 9,00,000 - ₹ 12,00,000 per year

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

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