Manager - API

5 hours ago

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

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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