Sr Executive

19 hours ago

AHMEDABAD WEST GUJARAT VIROCHAN NAGAR STAFF INDIA Troikaa Group Full time ₹ 12,00,000 - ₹ 18,00,000 per year
  • Responsible for following activities as QAMS investigation.
  • Monitoring of lab to ensure the activities is performed as per cGXP.
  • Performing investigation for incident, OOT, OOS and Deviation, Drafting reports and Closing of events like incident, OOT, OOS and deviation within the timeline.
  • Preparation of hypothesis protocol as per requirement in investigation.
  • Initiate CAPA in QAMS based on investigation outcome and coordinate with Doc-Cell team to implement it.
  • Responsible for 5S implementation in QC lab.
  • Preparation of trending report of OOT, Extraneous peak and Incident.
  • Preparation of Reduce testing report and investigate for any abnormality.
  • Responsible for following activities as in role of deliverance:
  • Daily basis tracking of FP and in process product sample, planning of HPLC analysis and release of results on Commitment basis.
  • Preparation of Quality results on RRT wise sheet.
  • Planning of Process validation samples, Hold time, intermediate and Stability sample for analysis.
  • Interaction with reviewer for completion of review of documents on timely to achieve SLA.

Responsible for following activities as analyst in QC:

  • To operate instruments- HPLC (SHIMADZU PROMINANCE-I, SHIMADZU LC2010 & DIONEX ULTIMATE 3000) on Chromeleon Software, GC, Karl fisher and PH METER Analysis of in-process, Intermediate, Finished, Raw material, Hold time, Stability Samples and process validation sample.
  • Compilation of documents and submission for review.
  • Monitoring of OOT immediately after completion of FP and stability sample analysis in Minitab software and reporting to in charge.
  • Reporting of laboratory incident and initiating in QAMS.

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