Technical Supervisor

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

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

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