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.