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Cipla Holding B.V.
Quality Control AnalystCipla Holding B.V. • Bilthoven, Utrecht, Netherlands
Sollicitaties worden niet langer geaccepteerd
Quality Control Analyst

Quality Control Analyst

Cipla Holding B.V. • Bilthoven, Utrecht, Netherlands
30+ dagen geleden
Functieomschrijving

Role Description


  • To ensure the compliance with Current Good Laboratory Practices as laid down in the Quality Control Procedures.


  • Maintenance or Upkeep of the Laboratory working areas.


  • Following the laid down safety precautions while working in the laboratory.


  • Analysis of Finished product.


  • Should review intimation documents for details and confirm the same is matching with the details of the sample and specification provided for the analysis.


  • Should read the relevant specification and organize the work in such a manner that testing can be completed in stipulated time.


  • Should be aware of potential problems that could occur during the testing process and should watch for steps that could create inaccurate results.


  • Should ensure use of instruments/ equipment’s meeting established performance specification and are properly calibrated.


  • Should ensure use of valid reagents, chemicals, standards, appropriate clean and dry glassware etc. for analysis.


  • Should follow correct analytical techniques during preparation of solutions like weighing, pipetting, dilutions, sonication, filtration etc.


  • Should follow specific instruction / Precautions provided based on material /Product characteristics in the respective specification.


  • Should perform testing of samples as per procedure specified in specification and make concomitant entries in test data sheet.


  • Should set parameters of instrument as given in specification and should ensure compliance of system suitability parameters before commencing for sample analysis.


  • Should follow cGLP for documentation.


  • Should ensure that the figures for quantitative tests are rounded to the number of decimals indicated in the standards of specification.


  • Should avoid transcription error during data entry and should ensure use of validated software for calculations.


  • Should check results for test performed for compliance with the standards specified in specifications and should not discard test preparations or standard preparations before the data are reviewed and verified.
  • Prompt reporting of abnormal observations of OOS, OOT, analytical incidences, instrument malfunctioning etc. or obvious error occurred during preparation to section Head.


  • Should ensure completeness of entries of all the tests performed and completion of relevant data before submission for review.


  • Involvement in the investigation of OOS, OOT or analytical incidences.


  • Disposal of balance samples after completion of analysis and review.


  • Involvement in the impact evaluation of instrument breakdown or calibration failures on previously released samples.


  • Maintenance of sample storage area at appropriate condition.


  • Maintenance of storage area of chemicals, Glassware and Stationary at appropriate condition.


  • Attending trainings and updation in Training index.


  • Performing analysis using various Instruments/Equipment’s available in the lab.


  • Involvement in the impact evaluation of instrument breakdown or calibration failures on previously released samples.


  • Calibration of instruments / equipment’s, preventive maintenance and validation as per specified schedule.


  • Maintenance of records of schedules, calibration, history files, preventive maintenance (Inhouse and outside), and validations.


  • Handling of breakdown of instrument / equipment as per procedure and follow up with service engineer for rectification.


  • Discontinuation and withdrawal of faulty or not in use instruments/ equipment from usage.


  • Maintaining stock/ Regeneration / washing of HPLC columns properly.


  • Maintaining of Glassware’s, Chemicals/Reagents, stationary items properly.


  • Preparation and review of different QC documents.


  • Any other assignment allocated by Head Quality.
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Quality Control Analyst • Bilthoven, Utrecht, Netherlands

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