Omschrijving : QC Analyst. Bedrijven : null. De locatie :

Qualifications - Master of Science in Chemistry with Experience and working knowledge of CGMP regulations is required.

Key Skills - English language is required.

· 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.

Job Type: Full-time

Salary: €25.000,00 - €35.000,00 per year

Education:

• Master's (Preferred)

Experience:

• QMS: 8 years (Preferred)
• Quality Control: 6 years (Preferred)
• Lab: 4 years (Preferred)
• Pharmacetical: 8 years (Preferred)