Manager - API

Travel

• 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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