• Follow cGMP and GLP practices in Quality Control Lab. • To monitor the stability program as per regulatory guideline and stability protocol. • To allocate the stability sample to analysis and destroy after completion of analysis. • To follow safety procedure in QC department. • To attend the training as per schedule. • To receive the samples for analysis and making entry in Inward register. • To maintain the Instruments log books related to sample analysis. • To review and approve the stability protocol and stability summary report. • To attend the regulatory / vendor audit and provide the compliance report. • Responsible for online documentation. • To review the incidence, OOS and OOT and take appropriate CAPA. • To review and approve the certificate of analysis of finished product, raw material. • To ensure current good laboratory compliance and ensuring all SOPs related to Quality Control laboratory are prepared and reviewed / implemented properly. • To follow safety Procedure in QC department. • To manage an accurate, reliable, efficient and timely review of finished products, in process/ validation, raw material, stability, GLP, Non-routine samples. • To ensure timely review of batch audit trail, system audit trail, message center. • To ensure review of Logbooks of instrument, equipment’s, columns, standards, impurities etc. • To review the COA of finished product in LIMS after the completion of analysis. • To ensure the status label updated for the instruments, equipment, glassware and workplace. • To conduct the training program to analyst as per the training calendar. • To ensure the training about the changes in standard operating procedures (SOP), if required. • To ensure the Sequence of HPLC/GC/IC are reviewed prior to start of the sample set. • To ensure methods are prepared accordingly STP/SOP. • To ensure proper integration and reviewed prior to E- signature of data by reviewer • To do any other Work assign by HOD.
