Principal Tasks &Responsibilities Quality Control analysis : • To maintain and adherence of the GLP and safety procedures in laboratory. • To raise the request for issuance of work data sheet / protocols. • Allocate the work to analyst as per planning. • To ensure that every specification and method of analysis used of right product/material code. • To follow the instruction of Shift /Section In charge for analysis /planning. • To report any QI/NQI/OOS/OOT / Deviation/ discrepancy in laboratory analysis to QC- In charge. • To ensure all the entries and results are in line with current specifications and STPs. • To prepare standard operating procedures, work data sheets and other documents related to QC. • To ensure the all column performance and column entry are maintain in column logbooks. • To maintain instruments log books properly as per analysis. • To provide training to concerned person to update the cGMP system update technical knowledge. • To ensure that analytical data in work data sheets / protocols for raw material /intermediates /APIs and etc... As per current specification and method of analysis. • To ensure reference / working standard/impurity standard usage records. • Review of in-process, Intermediate, Raw material, analytical data and approval for further processing of the batch. • To ensure that the maintain of instrument history record. • To ensure Daily monitoring and recording of temperature and humidity of refrigerator / working standard chamber and laboratory area. • To be plan holding time study of intermediates and preparation of reports. • To prepare/ check the protocols & reports for analytical method validation and analytical method transfer • Inform and Investigate OOS results in RM/Intermediates/APIs • Initiation of change control / deviations / NQI / QI/OOT related to QC. • Ensure that all documents / records required for Regulatory Compliance are maintained properly. • Review of SOP’s for regulatory compliance and actual practice. • To prepare list of chemical which required for HPLC analysis and inform for indents. • To ensure the analytical documents like specification, protocol, STP, are prepared as per SOP. • Ensure timey report and completion of reports of NQI, OOS, OOT, deviation, customer / market complaint investigation and change control. • Ensure all issues related to completed batches are resolved and documents are submitted to QA. • To maintain instruments logbooks properly as per analysis. • To maintain the GLP and GMP practices & ensure standards procedures followed in Quality Control laboratory effectively. • To review the Standard Operating procedures, work sheets/protocols of Hold time / stability / validation / qualification and other relevant documents of Quality control department. • To ensure awareness about the MSDS to all concern persons. • To educate and train the workmen for safe handling of chemicals, gas, cylinder and laboratory instruments to prevent the accidents. • To ensure the storage of laboratory chemicals and test samples at proper place with segregation to prevent accidents. • To ensure no spillage of lab. Chemicals / solvents • To coordinate with QA department for cGLP system • To coordinate with production department for on line analysis by proper planning/clubbing of analysis. • Give necessary for the supervisors for continuing the Production activities effectively. • Inform / Discuss with Department Head for any breakdowns, Deviations, quality issues, etc. for investigation and documentation. • Prepare and submit reports as required. • To ensure the storage of lab chemicals and test samples at proper place with segregation to prevent accidents.
