Manager - Quality Control

1 week ago

Dadra and Nagar Haveli, India SUN PHARMA Full time
Position: Manager IJob Grade: G10Function: Quality ControlSub-function: Raw MaterialLocation: DadraNo. of Direct Reports (if any): 13Job Responsibilities:
  • Planning and analyzing Raw material/ Retest material with Production and Warehouse Department.
  • Monitoring volumetric solution and reagents including documentation as per SOP.
  • Participating in laboratory failure investigations, root cause identification, and corrective actions.
  • Planning and monitoring sampling activities.
  • Monitoring Control sample and Out lab testing.
  • Evaluating and implementing Pharmacopoeial changes.
  • Planning analysis for Working Standard and Vendor samples.
  • Responsible for sample management in the Raw Material section.
  • Handling QMS activity in trackwise system.
  • Executing Gap Assessment related to Raw Material section.
  • Monitoring RM section analyst productivity.
  • Conducting training on CAPA/ OOS/ OOT/ Lab events.
  • Coordinating document submissions required by RA.
  • Imparting training to RM Section analysts.
  • Providing inputs for report preparation.
  • Reporting any abnormalities during analysis.
  • Ensuring availability of standards for Raw material analysis.
  • Ensuring SOP, Specification, ATP revision in RM section.
  • Ensuring cleaning procedures in Sampling devices.
  • Monitoring compliance related to RM section.
  • Monitoring QC laboratory cleanliness and upkeep.
  • Participating in review & approval of SOPs.
  • Ensuring laboratory safety, hygiene, and GLP standards.
  • Following GDP, GMP, and Data Integrity compliance.
  • Tracking and reconciling EDMS forms.
  • Performing any other additional assigned activities.

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