The Offer

• Work in a company with a solid track record of performance

The Job

ROLES AND RESPONSIBILITIES:

• 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 Stationery at appropriate condition.
• Attending trainings and updating 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.

The Profile

• Should be a Bachelors/Master of Science in Chemistry with Experience and working knowledge of CGMP regulations is required.
•  Key Skills – Fluent English language is required.

The Employer

Our client is a staffing firm hiring for QC Analyst for one of our renowned clients in Bilthoven, Netherlands.