Qvents

Qvents

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Biocon Biologics Limited
Designation : Executive
Function : QC
Functional Area : Quality Control Biosimilars
Job Role Summary : Analytical Method Validation, Method Transfer, Stability, Analytical Instruments Qualification, Calibration
Job Profile :
  • Preparation of method validation, method transfer, study protocol, Stability protocols and summary sheet (Compilation Data) and reports.
  • Planning and performing (Testing) of method transfer, method validation and study samples.Preparation, qualification and life cycle management of cell banks used in bioassays.
    Calibration of analytical weighing balance, HPLC, UV, IR, and pH meter etc.
  • Ensure & Implementation of Data Integrity Culture in Quality Control Lab.
  • Adherence to cGMP (Current Good Manufacturing Practice), cGLP (Current Good Laboratory Practice) and GDP (Good Documentation Practice).
  • Qualification of Analytical instruments and Equipment (IQ/OQ/PQ) and Facility readiness.
  • Escalation of Quality events (Critical and Data integrity) to department headfor further actions.
    To follow GDP and to ensure GDP are followed in all documents during review and approval
  • Verification of laboratory compliances to ensure GLP, which include the validity checking of the reagents, standards, system status etc.
Job Requirements :
  • Experience: 1 - 3 years
  • Pharma QC, Experience in Analytical Validations, Method transfers
Work / Job Experience : 1-2 Years
Type of Experience : QC Biosimilars
Academic Qualifications :

M.Sc, 

Website Linkedin Biocon Biologics Limited

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