Manager

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.