Work from Office
Full Time
Job Description Hands on industrial experience in Biotech/ Biologics industry on Raw/ Packaging Material Testing. Basic Knowledge/ Hands on experience in handling of equipment s pertaining to RM/PM testing including but not limited to HPLC/GC/UV-visible Spectrophotometry, FTIR, Polarimeter, Refractometer, Autotitrator, TOC analyzer, Weighing balance, pH/ conductivity meter, Melting range apparatus, Viscometer. Familiar with the basic cGMP systems including but not limited to sample management, OOS/OOT, Documentation control, Change Control, Audits, Deviation CAPA Management. Timely sampling testing of Raw/Packaging/ Consumable materials as per Pharmacopoeial/In-house procedures. Perform Daily sampling testing of Utility samples with online documentation trending. Preparation of SOP s/ STP s/ equipment URS/ Qualification/ Study protocols/ reports pertaining to RM/PM section Perform daily calibration/ verification/ requalification of analytical equipment s as per the approved procedures calibration/ verification frequency with online documentation. The candidate should be conversant with Quality module of SAP and LIMS system. Timely Updation of RM/PM/CM and water analysis results in SAP and LIMS system. The candidate should be conversant procedure for procurement of chemicals/ Reagents/ consumables and maintain their inventory records. To Ensure cGMP compliance in laboratory and ensure that the laboratory is always maintained in audit ready status. Work Experience 3 to 5 years Education Masters in Chemistry or Biochemistry Competencies
Lupin
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