• To perform the analysis of In-Process, Finish & Stability samples in Penicillin QC lab Dholka. • To ensure current good laboratory compliance and ensuring all SOPs related to Quality Control laboratory are prepared and reviewed/implemented properly. • To manage an accurate, reliable, efficient and timely testing of finished products, in process/ validation samples. • To ensure the compliance of GLP in Quality Control Lab. • To analyze the In-Process, Finish & Stability samples as per monthly calendar by chemical / instrument method. • To receive the samples for analysis form stability chamber and their management in QC up to analysis completion. • Responsible for preparation of stability protocol and grid if required. • To review the instruments log books related to In-Process, Finish & Stability samples document if required. • Responsible for initiation of OOS, OOT and incidences. • Timely provide the In-Process, Finish & Stability samples data without any delay. • Responsible for timely complete the analysis as per In-Process, Finish & Stability samples management SOP. • To maintain the column usage and records of impurities and working standard / reference standard during stability samples analysis. • Responsible for cleaning & monitoring of laboratory. • Responsible for taking of Continuations sheet (CS) and print out Record of analysis (ROA) for analysis. • To review timely release of batch audit trail, system audit trail, message center. • To review of logbooks of instrument, equipment’s, column, standards, impurities etc. • To review the COA of product in LIMS after the completion of analysis. • To review the status label updated for the instrument, equipment’s, glassware and workplace. • To provide the training program to analyst as per the training calendar. • To review the training about the changes in standard operating procedures (SOP), if required. • To review and sign in raw date as per specifications & Test procedure. • To review methods are prepared according to STP/SOP. • To review proper integration and prior to E-signature of data. • To investigate and file deviation, change control, Out of Specification (OOS), Out of Trend (OOT), Lab Incident, report whenever observed. • To review the calibration and preventive maintenance data. • To review working Standard and Reference standard qualification data. • To ensure that the Quality control always kept clean and presentable at all time. • To do all work as per the instruction of HOD. • Ensuring GLP compliance & Analysis of FP/In process/Validation/Raw Material samples in Penicillin QC lab, Dholka. • Ensuring GLP compliance & Analysis of FP/In process/Validation/Raw Material sample, Stability and Raw Material sampling in Penicillin QC lab, Dholka. • To ensure the compliance of GLP in Quality Control Lab. • To analyze the finished products, In-process and Raw Material sample by chemically / instrumental method. • To receive the samples for analysis and making entry in Inward register. • To maintain the Instruments log books related to FP analysis. • To analyze the validation sample and compilation of documents. • To enter the finished product results through LIMS. • Follow cGMP in Laboratory. Responsible for online documentation. • Responsible for taking of Continuations sheet (CS) and print out Record of analysis (ROA) through LIMS.
