A solution

Ambernath East, Thane

Education Qualification: MSc/Bsc (Chemistry)Experience Required: 2 -3 yrsLooking for a candidate who stays in mumbai only.Looking for experienced professionals for analysis on HPLC & or GC.Must have experience in API Manufacturing Facility or Analytical Testing Lab.Exposure to GMP and or GLP and ICH guidelines is a must. Work as per GMP/GLP / Sampling & Analysis of RM/PM/INT/FP/ Preparation, review of AMVP/AMVR/Method Verification/ Method Transfer/ Method Validation/ Microbiology/ Handling of regulatory Queries/ QMS / etc. Including but not limited to HPLC/GC/ Method Validation/ Review/ Approval/Method Transfer/AMC/ RS procurement & Management/ Change Control/OOS/OOT/CAPA/etc. Exposure to local GMP, ISO, OHSAS, USFDA, EDQM/EU inspections to maintain strict compliance for Validation Scientist & above. Prepare Specifications, AWRs, Lists and Schedules, SOPs, COAs and documentation activities.

To ensure analytical data generated is adequate and accurate for purpose.To perform analysis of stability study,working standard samples.To perform the analytical method validation.To work as per GMP/GLP in the laboratory