Manager
Posted Updated
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.