Mr. Amol Palande

• Review Analytical data (Documentation) of FG, RM, Stability and AMV,PV
• Section, Online-offline review and reviewing Incident ,OOS, OOT.
• Retrospective Review of HPLC, GC, UV-Visible Spectrophotometer, KF Autotitrator, AAS, ICPMS,IC, FTIR,GCMS etc i.e. monthly and Quarterly review of Audit trail.
• QMS Activity like Investigating Incidents, OOS, OOT,Significant change suggesting CAPA,Deviation, Change Control, SOP and Protocol preparation for non-routine analysislike Market Complaint or additional studies etc.
• Role in Audit: Compilation of Audit’s Product Related Documents and Reports. Re-Review of it and maintain necessary Compliance level throughout the day.
• Daily work planning of Stability and Finished Samples analysis with providing appropriate resources and its related trouble shootings.
• Sample Maintenance: Inward entry Finished product & Stability Samples, Its Storage according to its Compatibility, reconciliation and destruction after batch released
• Performed standardized tests on organic and inorganic compounds to observe fundamental differences in properties.

Technique/Instrument Known

• · HPLC (Waters,Shimadzu Dinox)
• · Software:-Empower2,3,Chromleon 7.2
• · GC (Perkin Elmer)
• · KF Autotitrater,Coulometer (Mettler Toledo)
• · UV-Visible Spectrophotometer(Perkin &Shimadzu)
• · FT-IR Spectrophotometer (Perkin,Shimadzu)
• · Polarimeter (Rudalph Research Analytical)
• · Analytical Balance(Mettler Toledo)
• · pH-Conductivity meter (Mettler Toledo)
• · UPLC (Waters Aquity)
• · Familier with Instrument like AAS,GCMS,IC,ICPMS.

• Sampling of raw material & water sample:-Sampling of Raw material and water samples On Daily basis per defined procedure and SOP.
• Analysis of Raw material & Water sample :-Analysis of Water
• sample of defined time point as per standard test procedure.
• Analysis of In-process,Finish & Stability sample:- Analysis of In process,FP And Stability sample of various Injectable product as per approved specification/protocol and within timeline specified.
• Calibration:-Daily & Monthly Calibration of various laboratory instrument such as Analytical Balance, pH- Conductivity meter, UV-Visible Spectrophotometer,FT- IR,Polarimeter,HPLC,UPLC and reported as per GDP on Daily and Monthly basis.
• Qualification of Working Standard:-Qualification of Working standard from current lot of Reference standard & Maintain working standard inventory.
• Test Performed:- Assay,Related Substances,Water Content.
• All physical & chemical testing.
• Well versed in GMP’S & GLP’S. Instruments operated as HPLC, UV-visible Spectrophotometer,FTIR,Karl-Fisher Auto Titrator, Coulometer,Polarimeter, Analytical Balance, pH-conductivity meter with respective Calibration.