QC Analyst/Sr. Executive
For FTE - Min 1 to 3 yrs experience
For Contarct - BSc Fresher
Qualifications - BSc/Master of Science in Chemistry with Experience and working knowledge of CGMP regulations is required.
Should be Experienced in :
Maintenance of the Laboratory
Reporting of abnormal observations of OOS, OOT, analytical incidences
Performing analysis
Key Skills - English language is required.
Requirement:
� To ensure 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 specifications and organize the work in such a manner that testing can be completed in the 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 meeting established performance specifications 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 the preparation of solutions like weighing, pipetting, dilutions, sonication, filtration etc.
� Should follow specific instructions / Precautions provided based on material /Product characteristics in the respective specification.
� Should perform testing of samples as per the procedure specified in the 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 tests 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 errors that 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 stationery at appropriate condition.
- Attending training and updation in the Training index.
- Performing analysis using various Instruments/Equipment available in the lab.
- Involvement in the impact evaluation of instrument breakdown or calibration failures on previously released samples.
� Calibration of instruments/equipment, preventive maintenance and validation as per specified schedule.
� Maintenance of records of schedules, calibration, history files, preventive maintenance (in-house 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, Chemicals/Reagents, and stationery items properly.
� Preparation and review of different QC documents.
� Any other assignment allocated by Head Quality.
