Sr.Executive QC

· Analysis of in process, intermediate, raw material, packaging material, ETP and utility samples, stability samples, R&D samples and other samples as per plant requirement as per defined STP’s.

· Well versed with advance analytical instrument like HPLC, GC, UV, IR, particle sizer, KF titrator.

· Calibration of all equipment in QC department as per SOP’s.

· To maintain the records of calibration, working standards, stability data, AMC, outside calibration records, instrument log book, validation report, in process and intermediates test reports as per GLP.

· To perform analytical method validation as and when required.

· To perform analytical method development project as and when required.

· To prepare and update the SOP’s and STP’s of QC department.

· To maintain 21 CFR part 11 compliance in the laboratory.

· To release the in process, intermediates samples within defined time line.

· To perform the sampling of raw materials, packaging materials as per sampling plan.

· To report any abnormality in analysis and timely reporting of OOS, incidence, disregard and deviation to the lab supervisor.

· To maintain calibration inside and outside, AMC and stability samples withdrawal schedule.

· To follow the instruction of lab supervisor for any specific task.