Metrologist

Sun Pharmaceutical Industries LtdChattanooga, TN

About The Position

Perform or assist with all essential tasks including troubleshooting, preventative maintenance, calibration, and qualification of laboratory instruments in accordance to all applicable SOP to ensure adherence to cGMP in support of the laboratory operation. Assist with instrument maintenance and schedule outside contractors where necessary.

Requirements

  • Troubleshooting laboratory instruments
  • Preventative maintenance of laboratory instruments
  • Calibration of laboratory instruments
  • Qualification of laboratory instruments
  • Adherence to cGMP
  • Documentation of raw data and observations
  • Adherence to safety procedures
  • Review and reporting of calibration/qualification documents
  • Instrument repair requests
  • Scheduling outside contractors for maintenance or repair
  • Labeling of instruments and calibration status
  • Maintaining spare parts for instruments
  • Verification of expiry dates for chemicals, reagents, and calibrators
  • Training and mentoring
  • Involvement in CAPEX process
  • Suggesting new or replacement instrument requirements

Responsibilities

  • Preparation of master Preventive Maintenance/Calibration schedule.
  • Planning, execution and review of instrument calibration/qualification related activities as per the calibration masterplan.
  • Perform the troubleshooting of laboratory instruments and ensure they are up and running.
  • Draft and review of instrument operation, maintenance and calibration procedures.
  • Initiate change controls for new and existing instrument and its procedures.
  • Author SOP for new instruments.
  • Concurrent documentation of all the raw data, observations in the notebook or applicable documents.
  • Notify to the supervisor any anomalous or OOC results. Notify the management for any observations or deviations.
  • Adhere to cGMP and safety procedures.
  • Review and report any applicable calibration/qualification documents.
  • Logging and attending instrument repair requests.
  • Scheduling visit for outside contractors for preventive maintenance or repair.
  • Placing “out of service tag” on instrument due for calibration, instrument requiring a repair or on a new instrument.
  • Opening the investigations and conduct primary investigation under direct guidance from management.
  • Ensure adequate labeling of all instruments and ensure instrument calibration status.
  • Order and maintain spare parts for major instrument to ensure continuous support of the analysis.
  • Verify the expiry date of chemicals, reagents, primary calibrators prior to use.
  • Provides training and mentoring to less experienced Metrologist, as needed.
  • Involve in CAPEX process and suggest new or replacement instrument requirements for laboratory operation.
  • Provides training and mentoring to QC Chemists and Lab Technicians.
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