Assistant Manager - Quality Control (stability) Job in Naprod Life Science

Assistant Manager - Quality Control (stability)

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Job Summary

Roles and Responsibilities :

  • Ensure that Stability protocol is approved before charging of stability samples, tracking of stability samples and analysis within defined time intervals.
  • Responsible for receipt management and inventory of stability samples
  • Responsible for planning and execution analysis of stability samples within defined window frame
  • Review the results with previous time points and identify OOT and conduct investigation
  • Responsible for review chromatographic data audit trial of computerized QC instrument
  • Responsible to maintain the department, equipment and its premises to be clean and to comply cGMP
  • Responsible for handling training and its continuation of the planned training as per yearly planner
  • Handling QMS a. Deviations, b. Incidents in quality control, c. Change Control, d. Out of Specification, e. out of trend result
  • Handling regulatory audits and its compliance
  • Responsible to GLP procedure follow, facility and document updating
  • Role in LIMS - All QC approvals
  • Roles in Master Control - a. Originator of Change control, b. Originator of deviation, c. Originator of incident report, d. Originator of out of specification

Desired Candidate Profile

  • 8 to 12 Years of Quality Control Experience in Stability
  • Exposure working with liquid injectable
  • Experience with Oncology is added advantage



Experience Required :

8 to 12 Years

Vacancy :

2 - 4 Hires

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