QC Officer Stability Section

13 hours ago

Vapi, Gujarat, India CIEL HR Full time ₹ 2,00,000 - ₹ 6,00,000 per year

Post: QC Officer Stability Section

Experience 01 To 05 Years

Qualification B.Sc.  / M.Sc.

Role & responsibilities

  • To ensure compliance of Current GLP & GDP in QC Lab.
  • To prepare and review of QC SOPs, specification & MOA, general documents and validation/ qualification protocols and report.
  • To analysis of raw material / packing material / in-process / intermediates / finish product / stability samples etc.
  • To prepare master calibration schedule and maintenance schedule of QC instrument and to ensure timely completion.
  • To calibrates/verifies analytical instruments/balances.
  • To check the instrument usage logbooks, calibration records, Instruments maintenance records.
  • To perform chemical assays and standardizations of reagents.
  • To prepare SOPs, reviews for biannual review. Prepare Training outlines.
  • To maintain and control inventory of Reagents. Chemicals/glass wares.
  • Prepares analytical protocols & reports.
  • To investigate laboratory errors.
  • To validate instruments, equipments, processes, analytical methods.
  • To prepare and evaluate stability data.
  • To ensure the timely qualification and maintenance of reference/ working standards/ primary standards as per respective SOP.
  • To initiate the change control / deviation related to Quality control department and to investigate the OOS/ OOT results of raw material/ packing material/ in-process/ intermediates / finish products / stability samples as per the SOP in timely manner.
  • To analyse the samples on GC instrument & Headspace GC.
  • To prepare validation plan & protocol for process, AMV samples.
  • To record the results & do the proper filing as per mandatory requirement.

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