Description :

- 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,



effective 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.

📌 Senior Manager (Dholka)
🏢 Cadila Pharmaceuticals
📍 Dholka