Deputy Manager - Quality Control and Analytical Operations

Job Summary

The position entitles the incumbent to possess adequate practical and technical knowledge on the Quality control techniques and related instruments.

Job Responsibilities

• Preparation of Process validation protocol, Cleaning validation protocol and cleaning evaluation report, trending and establishment of LCL and UCL, APQRs and VMP supporting documents.


• Preparation of Trending reports (Raw materials, Intermediates and Finished API) as per the schedule.


• Re-evaluations, Temperature Mapping, Equipment change controls, DM water Validation, Environmental Monitoring, Calibration & Preventive Maintenance activities.


• Preparation, Review of protocols and reports for Equipment, Support system qualification.


• Execution and monitoring of Environmental monitoring Programs.


• Execution and monitoring of Temperature mapping study.


• Monitoring of Preventive Maintenance activities.


• Review of the executed BPCR’s /GCR’s and Manufacturing related documentation support.


• To ensure manufacturing documents are issued/archived as per procedure in line with manufacturing activities.


• To monitor and ensure the Dispatch activities initiated after the Quality release.


• Equipment and area clearance certification for product changeover.


• SAP transactions.


• Review of Analytical Test Data Sheets & Tests Reports for finished products, Intermediates, impurity standards and reference standards.


• Preparation of certificate of analysis for impurity standards and reference standards.


• Retain samples maintenance.


• Quality Control Laboratory rounds for monitoring online GLP compliance.


•  IPQA Activities in Manufacturing & Packing

Responsabilités inhérentes à l’emploi

Job Requirements

• Education:
  
  
  
  • M.Sc. / M. Pharma
  
  
  
  


• Knowledge, Skills and Abilities:
  
  
  
  • To Follow cGMP, Knowledge on ICH Q7, Experience in regulatory inspection like USFDA, TGA MHRA etc
  
  
  
  


• Experience:
  
  
  
  • 12 above Years
  
  
  
  

Exigences liées au poste