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Sr Analyst, Quality Control-1

0 years

2 - 6 Lacs

Indore

Posted:1 month ago| Platform: GlassDoor logo

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Skills Required

analysis stability report storage qc compliance reporting support calibration software documentation data audit management monitoring sampling testing

Work Mode

On-site

Job Type

Part Time

Job Description

Job Description Summary
  • To perform the analysis of in process sample, Hold Time, finished product, Swab & stability samples.

  • To prepare documents (SOP, Protocol, Format, STP, Specification, GTP, work sheet, COA and Report) whenever required.

  • To upkeep the laboratory working area, documents and records neat and tidy.

  • Receipt and storage of samples in QC sample room.

  • To attend and completion of trainings in Compliance wire on timely basis.

  • Timely reporting of incident, deviation, OOS and OOT etc. to group leader or designee and support in Laboratory Investigation.

  • To ensure timely destruction of samples as per standard operating procedure.

  • To take up allocated work assigned by group leader or designee for laboratory operations.

  • To ensure lab compliance during daily activities and follow safety, cGLP and cGDP in work area.

  • To perform the calibration of instrument before execution of activities whenever applicable.

  • Responsible for execution of analysis and sign off activities in software on timely manner wherever applicable.

  • To perform concurrent documentation of analytical records, storage of raw data, online entries in instrument/Equipment usage logbooks.

  • To be responsible all-time readiness for inspections or any audit conducted by regulatory authorities.

  • Follow all the safety procedures to maintain a safe working environment.

  • To monitor the employee’s safety aspects and guide them safety related importance.

  • Any non-conformity with regard to Environment Management System should be highlighted.

  • Responsible for temperature and humidity monitoring of stability chambers; and to address the failure whenever applicable.

  • To perform the analysis of Analytical Method Transfer, Market Complaint And Miscellaneous sample

  • To Perform Sampling And testing of cleaning swab samples

  • To ensure timely destruction of finished/In process/Swab/Stability/Hold time studies samples as per standard operating procedure
Job Description
NA

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