Assistant Manager

"• 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.
• Responsible for monitoring daily routine activity & follow good documentation practices.
• 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."