Opening for
Qc-hplc @ Cadila Pharmaceuticals Ltd. Ankleshwar
3 - 8 yrs
Opening
for QC-HPLC at Cadila Pharmaceuticals Ltd @ Ankleshwar
·
Position : Officer / Sr Officer /Executive
·
Qualification: M.Sc.
·
Experience : Minimum 3
Years (Hands on HPLC)
·
Job Location : Ankleshwar, Dist :
Gujarat
Job Profile:
To maintain and adherence of the GLP
and safety procedures in laboratory.
To raise the request for issuance of work data sheet / protocols.
To perform the analysis as per work allocation and records the results in work sheet / protocol and maintain on line documentation.
To work as Analyst / Operator as a level of users and maintain the CFR 21 part -11 compliance by following laid down procedures.
To perform all the HPLC related analysis of In-process, intermediate, finished products & returned goods / raw materials Hold time / Stability study /reference / working standard analysis as per laid down specification & test procedures , SOPs, as per work allocation and report the analysis data in LIMS modules and report to Section Head / Or QC head.
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 incidents / Deviation/ discrepancy in laboratory analysis to QC- In charge.
Responsible for performing calibration of laboratory instruments as per schedule and laid down SOPs with documentation and updation of instrument calibration status tag.
To record and 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 acquire training from concerned person to update the cGMP system update technical knowledge.
To record analytical data in work data sheets / protocols for raw material / packing materials/intermediates /APIs and etc.. as per current specification and method of analysis.
Preparation, qualification and management of working standard for Raw materials Intermediates/APIs.
To maintain instruments/ column usage log books for HPLC and GC.
To maintain reference / working standard/impurity standard usage records.
Review of in-process analysis data and approval for further processing of the batch.
To maintain instrument history record.
Joint analysis with R&D personnel during analytical method transfer on HPLC.
Preparation of stability protocols and stability reports.
To perform analysis of stability samples as per stability schedule
Daily monitoring and recording of temperature and humidity of refrigerator / working standard chamber and laboratory area.
Perform 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 / OOT related to QC.
Ensure CFR 21 part -11 compliance and follow good chromatography practices during analysis, integration and reviewing of on line and off line chromatographic analysis to maintain proper data integrity. Ensure that all documents / records required for Regulatory compliance are maintained properly.
Review SOPs 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 NQI, OOS, OOT, deviation, customer / market investigation and change control.
Ensure all issues related to completed batches are resolved and documents are transferred to QA.
To revise the SOP/STP as per schedule
To maintain instruments logbooks properly as per analysis.
To maintain the GLP and GMP practices & ensure standards procedures in Quality Control laboratory followed 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 raise the request for issuance of work data sheet / protocols.
To perform the analysis as per work allocation and records the results in work sheet / protocol and maintain on line documentation.
To work as Analyst / Operator as a level of users and maintain the CFR 21 part -11 compliance by following laid down procedures.
To perform all the HPLC related analysis of In-process, intermediate, finished products & returned goods / raw materials Hold time / Stability study /reference / working standard analysis as per laid down specification & test procedures , SOPs, as per work allocation and report the analysis data in LIMS modules and report to Section Head / Or QC head.
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 incidents / Deviation/ discrepancy in laboratory analysis to QC- In charge.
Responsible for performing calibration of laboratory instruments as per schedule and laid down SOPs with documentation and updation of instrument calibration status tag.
To record and 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 acquire training from concerned person to update the cGMP system update technical knowledge.
To record analytical data in work data sheets / protocols for raw material / packing materials/intermediates /APIs and etc.. as per current specification and method of analysis.
Preparation, qualification and management of working standard for Raw materials Intermediates/APIs.
To maintain instruments/ column usage log books for HPLC and GC.
To maintain reference / working standard/impurity standard usage records.
Review of in-process analysis data and approval for further processing of the batch.
To maintain instrument history record.
Joint analysis with R&D personnel during analytical method transfer on HPLC.
Preparation of stability protocols and stability reports.
To perform analysis of stability samples as per stability schedule
Daily monitoring and recording of temperature and humidity of refrigerator / working standard chamber and laboratory area.
Perform 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 / OOT related to QC.
Ensure CFR 21 part -11 compliance and follow good chromatography practices during analysis, integration and reviewing of on line and off line chromatographic analysis to maintain proper data integrity. Ensure that all documents / records required for Regulatory compliance are maintained properly.
Review SOPs 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 NQI, OOS, OOT, deviation, customer / market investigation and change control.
Ensure all issues related to completed batches are resolved and documents are transferred to QA.
To revise the SOP/STP as per schedule
To maintain instruments logbooks properly as per analysis.
To maintain the GLP and GMP practices & ensure standards procedures in Quality Control laboratory followed effectively.
To review the Standard Operating procedures, work sheets/protocols of Hold time / stability / validation / qualification and other relevant documents of Quality control department.
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