Manager- QA

4 weeks ago


Hyderabad, India Sai Life Full time

Key Responsibilities:

  • Ensuring compliance in Quality control laboratory w.r.t. SOP's and regulatory requirements.
  • Imparting training to QC Associates on SOP's and current regulatory requirements based on the review observations.
  • Review of Analytical data such as Finished, Intermediate, Raw material and Stability.
  • Review of electronic data and sequence audit trail against hard copy to ensure the accuracy of the analytical data.
  • Review of Stability Protocols, Stability schedules and Stability data sheets.
  • Review of master list of instruments, equipment's and Qualification document.
  • Review of Preventive maintenance schedules, Calibration schedules and Calibration data of all Analytical Instruments in Quality control laboratory.
  • Review of Method transfer/Method verification/Method validation protocols and Reports including Raw Data.
  • Review of Reference Standards/Working Standards, data including Certificate of Analysis.
  • Preparation of quality comparison sheets for all dispatched material to ensure the analytical trend.
  • Review of monthly comprehensive assessment reports, laboratory errors and invalidation.
  • Review of Analyst Qualification raw data.
  • Audit trial review of all the standalone instruments and Empower in Quality control department.
  • Review of certificate of analysis.

Key Competencies (Technical, Functional & Behavioral)

  • Excellent verbal and written communication
  • Persuasiveness
  • Inter-personal skills
  • Adaptability
  • Foresight
  • Understanding of business processes.

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