QA Documentation - Gurgaon, India - Ls Hireman consulting Pvt Ltd

Deepika Kaur

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Deepika Kaur

beBee Recuiter


Description

Current JOB Responsibilities:

  • Quality management system (QMS) and Documentation.
  • Handling of Change control.
  • Handling of Deviation.
  • Handling of CAPA.
  • Handling of OOS investigation and preparing trend analysis of OOS.
  • Handling of Incidents and investigating CAPA to close incidents and Prepare
  • Trend analysis of Incidents.
  • Handling of OOT and involve investigating root cause and impact of OOT.
  • Investigations & root cause analysis.
  • Audit trails for analytical instruments in QC of software s e.g., Lab solution,
  • LC solution, Open LAB, PAMAS-USP for TOC, Tiamo2.5 for Auto titrator,


  • Advance expertViatek

  • Reviewing & Preparation of Standard Testing Procedures.
  • Reviewing & Preparation of Standard Operating Procedures.
  • Review of Stability Protocols and summary sheet.
  • Preparation & Review of DATA for Regulatory Department.
  • VALIDATION / QUALIFICATIONS /CALIBRATIONS
  • Stability study.

Qualification :
B.sc, M.sc, B. pharma, M.pharma.


  • Process validation.
  • Analytical Method Validation.
  • Qualification of instruments.
  • Calibration of instruments.
  • Analyst validation.
  • Instrument handling.
  • Handling of HPLC Prominence
  • I/Shimadzu.
  • Handling of GC.
  • Handling of UV.
  • Handling of Auto titrator

Job Types:
Full-time, Regular / Permanent


Salary:
₹18, ₹22,000.00 per month


Ability to commute/relocate:

  • Gurgaon, Haryana: Reliably commute or planning to relocate before starting work (required)

Education:


  • Bachelor's (preferred)

Experience:

- total work: 3 years (preferred)

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