Senior Manager
Job 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, 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.