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 (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 notinuse 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.
quality control procedures,quality control,finished product analysis,preparation and review of qc documents,high-performance liquid chromatography (hplc),maintenance of laboratory,safety precautions,analytical techniques,instrument control,validation,calibration,laboratory working areas,chemicals/reagents maintenance,cgmp regulations,documentation,english language,hplc-ms,testing,glassware,oos,reading relevant specifications,chemicals
Quality Control yst
