GU

Sr. Officer / Officer - QC ( HPLC Analysis)

Gufic Group
Pithampur ₹2-7 LPA Posted 21 May 2025
FULL TIME
21 Cfr Part 11
Hplc
Pharma
Glp
data integrity

Job Description

Job Profile:

  • Responsible for analysis of IP/FP/,PV, Semifinished products, hold time samples
  • Responsible for maintaining compliance and to ensure GLP in lab.
  • Responsible for analysis of samples on HPLC/GC etc.
  • Responsible to provide request to section head for issuance of AWR and to record analysis related activities
  • Responsible to receive samples of FP/IP/inprocess/,holdtime samples and maintain the record.
  • Responsible for reconciliation and destruction of laboratory samples.
  • Responsible to maintain records for FP/IP/PV/SFG/Holdtime samples
  • Responsible for preparation of COAs
  • Responsible to maintain individual training record
  • Responsible for record details of OOS/OOT/OOC/Incidents and to participate in laboratory investigation.
  • Responsible for flushing of HPLC System as per schedule.
  • Responsible for execution of qualification of laboratory instruments
  • Responsible to maintain documents as per GLP and GMP system
  • Responsible to maintain Data Integrity in lab.

Desired Candidate Profile

  • Candidate Should be from Pharma - injectable formulation background.
  • Should have knowledge of 21 CFR Part 11.

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