Quality Control Analyst

Cipla Holding B.V.; Bilthoven; On-site; EUR 38,000 - 54,000; Full time

Job summary

Cipla Holding B.V. in the Netherlands seeks a Quality Control Analyst to execute routine QC operations and stability studies, ensuring compliance with GLP guidelines and regulatory requirements.

Responsibilities include maintaining lab areas, reviewing intimation and specifications, calibrating instruments, using valid reagents and glassware, and documenting results in the data sheets as per procedures.

Qualifications

• Experience with GLP and QC testing per pharmaceutical standards.
• Maintaining laboratory areas and following safety precautions.
• Ability to analyze finished product and review documents.
• Knowledge of instrument calibration and use of reagents and glassware.
• Follow specifications and documentation practices per cGLP.

Responsibilities

• Ensure compliance with cGLP per QC procedures.
• Maintain laboratory work areas.
• Follow safety precautions in the lab.
• Analyze finished product.
• Review intimation documents for details and match with sample specs.
• Read relevant specifications and organize work to meet testing timelines.
• Be aware of potential issues affecting accuracy and take corrective actions.
• Ensure instruments/equipment meet performance specs and are calibrated.
• Use valid reagents and clean glassware for analysis.
• Follow instructions for preparation of solutions and testing per spec.
• Record data accurately and ensure proper data entry and validation.

Skills

Quality control

GLP compliance

Laboratory safety

Education

M. Sc, B. Pharm, M. Pharm

Tools

HPLC

Job description

Job Purpose:

Execute quality control routine operations and stability studies and confirm testing as per the GLP guidelines and regulatory requirements. To ensure the compliance with Current Good Laboratory Practices as laid down in the Quality Control Procedures.

Key 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 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.

Qualification:

M. Sc, B. Pharm, M. Pharm